FDA · Medical device recall

Giraffe¿ Infant Warmers… and 5 more products

Feb. 12, 2014 Class II

Date: Feb. 12, 2014
Risk class: Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
Status: Terminated
Filed by: GE Healthcare
Reason: Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients.
Distribution pattern: Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Uruguay, Venezuela, Albania, Algeria, Australia, Austria, Bahrain, Belarus, Belgium, Bolivia, Canada, Chile, China, Costa Rica, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Kazakhstan, Korea, Kuwait, Lithuania, Macedonia, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Nigeria, Norway, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, United Arab Emirates, and United Kingdom.

6 products in this recall

Giraffe¿ Infant Warmers…

Product: Giraffe¿ Infant Warmers, part number M1118179, labeled in part *** GE Healthcare 8880 Gorman Road Laurel, MD 20723***www.gehealthcare.com* Giraffe¿ Infant Warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology.
Quantity: 1970 units
Codes and lots: Serial Numbers: HDJR52093 HDJQ52878 HDJS51010 HDJP51983 HDJN52273 HDJN52274 HDJN52275 HDJN52276 HDJP50604 HDJP50605 HDJM50388 HDJR56613 HDJQ52689 HDJR50734 HDJR50735 HDJS50028 HDJP52371 HDJP52558 HDJN51693 HDJN51694 HDJR56618 HDJQ51960 HDJS52390 HDJM50693 HDJM51714 HDJM51716 HDJM51717 HDJM51718 HDJM52096 HDJN52193 HDJN52194 HDJN52195 HDJN52196 HDJN52197 HDJP52562 HDJP52563 HDJP52564 HDJP52565 HDJQ52920 HDJQ52917 HDJQ52918 HDJQ52919 HDJQ52921 HDJQ52922 HDJQ52923 HDJQ52924 HDJQ52925 HDJQ52926 HDJQ52927 HDJQ53075 HDJR56481 HDJR56482 HDJR56486 HDJR56487 HDJR56488 HDJR56489 HDJR56490 HDJR56491 HDJR56358 HDJP50531 HDJP50532 HDJR56107 HDJR56370 HDJR56669 HDJR56746 HDJR56747 HDJR56748 HDJM51930 HDJM52089 HDJM51405 HDJM51470 HDJM51471 HDJM51472 HDJM51475 HDJM51847 HDJS51291 HDJS51292 HDJR54229 HDJQ51474 HDJQ51475 HDJQ51476 HDJM52059 HDJM50272 HDJP50634 HDJQ51827 HDJR50477 HDJR57730 HDJM50483 HDJQ52812 HDJS52096 HDJR57172 HDJM50694 HDJN51776 HDJN51777 HDJN51778 HDJQ51257 HDJR56005 HDJR56006 HDJR56007 HDJR56008 HDJQ52597 HDJQ52598 HDJQ52599 HDJQ52600 HDJQ52601 HDJN50850 HDJM50704 HDJM50705 HDJM50706 HDJM50707 HDJM50708 HDJM50709 HDJQ53073 HDJR57718 HDJP50352 HDJM50012 HDJP51078 HDJP51079 HDJP51080 HDJQ51561 HDJQ51562 HDJQ51563 HDJR56749 HDJR56750 HDJR56751 HDJR56752 HDJR56753 HDJS50790 HDJS50791 HDJS50792 HDJR57719 HDJR57720 HDJR57721 HDJQ50915 HDJQ50916 HDJQ50917 HDJQ50918 HDJQ50919 HDJS51692 HDJS51693 HDJM51900 HDJM52091 HDJM52092 HDJM52093 HDJS50046 HDJS50047 HDJS50048 HDJR50230 HDJR50231 HDJS50297 HDJP51783 HDJP51784 HDJP51792 HDJP51793 HDJP51796 HDJQ52082 HDJS50733 HDJS50734 HDJS50735 HDJP52863 HDJR50596 HDJR50597 HDJR50598 HDJN50595 HDJM50200 HDJM50201 HDJP52156 HDJP52071 HDJP52072 HDJQ52813 HDJQ52814 HDJQ52815 HDJQ52895 HDJS51414 HDJS51415 HDJS51417 HDJM51320 HDJM51321 HDJM51883 HDJN50762 HDJN50763 HDJN51327 HDJS50042 HDJS50043 HDJR50133 HDJR50134 HDJR50135 HDJR50136 HDJR50138 HDJR50139 HDJR50140 HDJR50141 HDJR50142 HDJR50144 HDJR50145 HDJR50146 HDJR50147 HDJR50148 HDJR50149 HDJR50150 HDJR50151 HDJR50152 HDJR50153 HDJR50154 HDJR50155 HDJR50156 HDJR50158 HDJR50159 HDJR50161 HDJR50143 HDJR50157 HDJR50160 HDJR50299 HDJL50161 HDJL50162 HDJL50163 HDJL50164 HDJL50165 HDJR50298 HDJS51009 HDJP50561 HDJP50562 HDJP50563 HDJP50564 HDJP50565 HDJP50566 HDJQ52690 HDJS50002 HDJS50003 HDJS50004 HDJS50005 HDJS50006 HDJS50007 HDJL50357 HDJL50358 HDJL50360 HDJL50362 HDJL50359 HDJL50383 HDJR52099 HDJR56206 HDJN51948 HDJN51949 HDJN52121 HDJN52122 HDJP52630 HDJP51794 HDJP51795 HDJP52794 HDJP52795 HDJN52437 HDJN52438 HDJN52439 HDJS52720 HDJS52721 HDJR54274 HDJR54275 HDJR52095 HDJR54268 HDJR54269 HDJR54270 HDJR54271 HDJR54272 HDJM50005 HDJM50006 HDJM50007 HDJS51006 HDJS51002 HDJS51003 HDJS51004 HDJS51005 HDJN52376 HDJP50730 HDJR56133 HDJM51307 HDJS51426 HDJS51427 HDJS51458 HDJP51526 HDJP51527 HDJP51528 HDJP52796 HDJP52797 HDJP52798 HDJR56368 HDJR57717 HDJR56207 HDJL50432 HDJL50433 HDJL50434 HDJL50435 HDJQ51484 HDJQ51485 HDJQ51486 HDJQ51487 HDJQ51488 HDJQ51489 HDJQ51490 HDJM51308 HDJP50177 HDJR56361 HDJP51389 HDJP51390 HDJP51391 HDJN50262 HDJN50263 HDJN50264 HDJN50265 HDJP52079 HDJP52080 HDJP52081 HDJP52082 HDJN50541 HDJN50542 HDJN50543 HDJN50544 HDJN50545 HDJN50546 HDJN50547 HDJN50298 HDJN50299 HDJR54214 HDJR54215 HDJR54216 HDJQ50580 HDJQ50581 HDJQ50582 HDJQ50583 HDJQ50584 HDJQ50585 HDJM50056 HDJM50178 HDJM50583 HDJM51924 HDJM52339 HDJM50651 HDJR52092 HDJR52098 HDJM50058 HDJM50097 HDJN51392 HDJR58028 HDJR58029 HDJR58030 HDJR58031 HDJM50142 HDJQ50388 HDJQ50389 HDJQ53023 HDJQ53024 HDJQ53025 HDJQ53026 HDJQ53027 HDJQ53028 HDJQ53029 HDJQ53030 HDJQ53031 HDJN51333 HDJN51855 HDJN51856 HDJN51857 HDJN51858 HDJN51859 HDJN51692 HDJN50786 HDJN50785 HDJN50787 HDJN50788 HDJQ52080 HDJQ52081 HDJR57435 HDJR57436 HDJR57437 HDJR57438 HDJR57439 HDJR57751 HDJS51416 HDJS51554 HDJS51555 HDJS51556 HDJQ51789 HDJQ51792 HDJM50343 HDJP52606 HDJP52607 HDJM51449 HDJM50903 HDJM50904 HDJM51596 HDJM51597 HDJM51598 HDJM51599 HDJM51759 HDJM51760 HDJM51340 HDJP51984 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HDJP52745 HDJQ53048 HDJQ53049 HDJQ53050 HDJL50240 HDJL50243 HDJL50244 HDJL50245 HDJM50063 HDJM51079 HDJM51080 HDJM52050 HDJN52322 HDJN52323 HDJL50521 HDJL50522 HDJL50523 HDJL50491 HDJL50493 HDJL50494 HDJL50517 HDJQ51992 HDJQ52894 HDJQ52903 HDJQ52904 HDJQ52905 HDJQ52907 HDJQ52908 HDJQ52909 HDJQ52910 HDJQ52629 HDJS50899 HDJN51149 HDJN51150 HDJN51151 HDJN51152 HDJR57307 HDJR57308 HDJP50601 HDJP50606 HDJQ52897 HDJQ52108 HDJQ52109 HDJQ52110 HDJQ52111 HDJQ52112 HDJQ52113 HDJQ52877 HDJR56205 HDJR56371 HDJR56372 HDJR56373 HDJR56374 HDJR56667 HDJR56668 HDJR56369 HDJP50216 HDJP50217 HDJP50218 HDJP50219 HDJP50220 HDJP50221 HDJP50222 HDJP50224 HDJP50223 HDJQ51609 HDJQ51610 HDJQ51611 HDJP50635 HDJS50199 HDJS52092 HDJS52093 HDJM51420 HDJM51422 HDJM50436 HDJM50437 HDJM50438 HDJM51438 HDJM51439 HDJM51440 HDJM50580 HDJM50581 HDJM50582 HDJM51682 HDJM51683 HDJM51715 HDJR57968 HDJR57969 HDJR57970 HDJR57971 HDJM50480 HDJM50481 HDJM50482 HDJR57729 HDJQ53076 HDJL50364 HDJN51217 HDJN51218 HDJS52118 HDJQ51343 HDJQ51344 HDJQ51345 HDJQ51346 HDJN51854 HDJP50146 HDJP50178 HDJN51744 HDJM50288 HDJM50289 HDJN51698 HDJR50137 HDJN50593 HDJN50594 HDJR57565 HDJR57566 HDJR57567 HDJR57568 HDJR57569 HDJR57563 HDJR57564 HDJM50695 HDJS50694 HDJS50696 HDJS50736 HDJS50737 HDJM50504 HDJS51325 HDJS51278 HDJS51279 HDJN51210 HDJS52737 HDJS52738 HDJS52739 HDJS52740 HDJM52106 HDJM50536 HDJM50537 HDJQ52617 HDJP50650 HDJP50651 HDJP50652 HDJR50510 HDJR50511 HDJR50512 HDJR50513 HDJR50514 HDJR50515 HDJQ50539 HDJQ52202 HDJQ52203 HDJM51184 HDJM51185 HDJM51186 HDJM51187 HDJM50538 HDJM50956 HDJM50957 HDJM50584 HDJN52351 HDJM51062 HDJM51063 HDJR56626 HDJR56627 HDJR56628 HDJS52715 HDJS52716 HDJQ52906 HDJR57440 HDJP51827 HDJP51828 HDJP51900 HDJM50008 HDJM50009 HDJM50010 HDJM50011 HDJM50421 HDJM50422 HDJP50354 HDJR54218 HDJR58033 HDJR58034 HDJR58035 HDJR58036 HDJM51419 HDJM51421 HDJM51423 HDJM51448 HDJR54219 HDJN50167 HDJN50168 HDJN50169 HDJN50170 HDJR57173 HDJL50195 HDJL50196 HDJL50197 HDJL50198 HDJL50199 HDJL50200 HDJL50201 HDJM51252 HDJM51257 HDJM51259 HDJM51253 HDJM51254 HDJM51255 HDJM51256 HDJM51258 HDJL50422 HDJL50423 HDJN52189 HDJN52190 HDJN52192 HDJN52191 HDJN50237 HDJN50238 HDJN50239 HDJQ50961 HDJQ50962 HDJQ50963 HDJQ50964 HDJQ50965 HDJQ50966 HDJQ50967 HDJQ50968 HDJQ50969 HDJQ50970 HDJQ50971 HDJQ50972 HDJQ50973 HDJQ50974 HDJQ51573 HDJR54164 HDJR54165 HDJR54217 HDJR56714 HDJR52094 HDJM51339 HDJP52018 HDJP52019 HDJP52359 HDJP52363 HDJP52513 HDJP51823 HDJP51824 HDJP51825 HDJP51826 HDJP51829 HDJP51830 HDJP51903 HDJP51904 HDJQ52488 HDJQ52489 HDJS50041 HDJS50616 HDJM50055 HDJM51931 HDJP52809 HDJP52810 HDJQ50153 HDJQ50154 HDJQ50155 HDJP51458 HDJP51459 HDJP51460 HDJQ51306 HDJQ51307 HDJQ51638 HDJQ51639 HDJR52104 HDJR52105 HDJR50765 HDJM51553 HDJM51554 HDJP50353 HDJP50602 HDJS52323 HDJN51946 HDJN51947 HDJQ51634 HDJQ51635 HDJQ51636 HDJQ51637 HDJN51957 HDJP51785 HDJP51786 HDJP51787 HDJP50547 HDJP50548 HDJR50065 HDJR50066 HDJM51794 HDJM52027 HDJM52028 HDJM52029 HDJM52030 HDJM52031 HDJM52032 HDJM52033 HDJM52034 HDJM52035 HDJN51601 HDJR54249 HDJR54250 HDJP51883 HDJP51950 HDJM50059 HDJQ52270 HDJS50159 HDJS50160 HDJN50583 HDJN51435 HDJN51436 HDJP51187 HDJP51188 HDJQ50419 HDJM51884 HDJM51885 HDJM52077 HDJQ51788 HDJQ51790 HDJQ51791 HDJP52233 HDJM51882 HDJS50854 HDJS51825 HDJS50459 HDJS50460 HDJS50461 HDJS50851 HDJS50852 HDJS50853 HDJS50855 HDJS51826 HDJQ50646 HDJQ50642 HDJQ50643 HDJQ50644 HDJQ50645 HDJQ50647 HDJR57725 HDJR57728 HDJP51862 HDJM52098 HDJN51697 HDJS52377 HDJS52378 HDJS52400 HDJN51211 HDJN51212 HDJN51213 HDJN51214 HDJN51215 HDJN51216 HDJM50645 HDJM50646 HDJM50647 HDJM50648 HDJM50649 HDJM50650 HDJN52254 HDJR56484 HDJR56485 HDJQ50385 HDJP51861 HDJP51882 HDJS51724 HDJS51725 HDJS51726 HDJS51727 HDJS51728 HDJS52111 HDJL50489 HDJL50490 HDJL50492 HDJL50518 HDJL50519 HDJL50520 HDJN51816 HDJN51817 HDJN51818 HDJM51848 HDJP52806 HDJP52807 HDJP50233 HDJP50234 HDJQ53173 HDJM50419 HDJM50420 HDJM50697 HDJR56933 HDJR56934 HDJM50386 HDJM50387 HDJM51216 HDJM51217 HDJM51218 HDJM51219 HDJM51220 HDJM51221 HDJM51222 HDJM51223 HDJM51224 HDJM51225 HDJM52221 HDJP50355 HDJP51523 HDJP51524 HDJP51525 HDJQ50951 HDJQ50952 HDJQ50953 HDJR54122 HDJR54123 HDJR56798 HDJP51633 HDJQ51525 HDJR50162 HDJM50187 HDJP50007 HDJN51837 HDJN51838 HDJN51839 HDJN51840 HDJQ50252 HDJQ50253 HDJQ50254 HDJQ50255 HDJQ50256 HDJQ50257 HDJQ50258 HDJQ50259 HDJP51022 HDJP51023 HDJR54166 HDJR54167 HDJR54168 HDJR54169 HDJR54170 HDJR54171 HDJR54172 HDJR54173 HDJN51896 HDJL50505 HDJQ50336 HDJQ50337 HDJQ50338 HDJQ50339 HDJQ50340 HDJQ50341 HDJS50695 HDJS50697 HDJS50738 HDJP51104 HDJP52352 HDJP52353 HDJP52354 HDJP52364 HDJP52626 HDJP52627 HDJP52628 HDJP52629 HDJS51797 HDJM50653 HDJR50225 HDJR50224 HDJP51901 HDJP51902 HDJM52302 HDJM52303 HDJN50376 HDJM52094 HDJM50652 HDJP51190 HDJP51191 HDJP50498 HDJP50499 HDJQ51491 HDJQ51492 HDJQ51493 HDJQ51494 HDJQ51495 HDJR56367 HDJN50815 HDJP51388 HDJS50950 HDJS51732 HDJR58208 HDJR58207 HDJR58209 HDJL50487 HDJN50573 HDJN50767 HDJM50902 HDJQ52058 HDJM50479 HDJP51951 HDJL50229 HDJL50230 HDJL50231 HDJL50232 HDJM50879…
Recall started: Dec. 12, 2013
Device type: Warmer, Infant Radiant
Root cause (FDA): Process control
What the company told customers: GE Healthcare notified end users with a letter flagged as Urgent Medical Device Correction letter on 12/12/2013. The notification advised that GE Healthcare has become aware of a potential safety issue associated with the loosening of the blender knob shaft on all Resuscitation units. The firm advised that accounts ensure that all potential users in their facility are made aware of this safety notification and the recommended actions described in the notification: 1. Perform blender accuracy check as outlined in Section 2.5-2.5.1 of the Service Manual to verify that the O2 concentration set at 21% is within 16-26% O2 and the concentration at 100% setting is within the recommended range (95-105% O2). 2. If the blender accuracy test results do not meet specifications, remove the unit from patient use and contact a GE Healthcare Service Representative at the number listed below. 3. If the blender accuracy check passes in Step 1 above, you may continue to use your resuscitation system. The following precautions are recommended to ensure blender accuracy is maintained between system checks. Use an independent oxygen analyzer, as determined by your hospital policy, to check blended Air/O2 accuracy. When delivering Oxygen, use a pulse oximeter to monitor your patient. Customers were requested to contact a GE Healthcare Service Representative at 1-800-345-2700 to arrange for correction if the device is found to be defective.
Recall number: Z-0912-2014

Panda iRes¿ Infant Warmers…

Product: Panda iRes¿ Infant Warmers, part number M1112198 and Panda Freestanding Warmers, part number 2063568, labeled in part *** GE Healthcare 8880 Gorman Road Laurel, MD 20723***www.gehealthcare.com** Panda Infant Warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology.
Quantity: 9232 units
Codes and lots: Serial Numbers: HDJQ52826 HDJR50704 HDJR54140 HDJR54141 HDJR54142 HDJR54143 HDJS50670 HDJS50671 HDJS50672 HDJS50678 HDJS50679 HDJS50681 HDJS50682 HDJS50684 HDJS50686 HDJR56405 HDJS52316 HDJP51364 HDJP51369 HDJP51376 HDJP51379 HDJP51380 HDJP51381 HDJR56387 HDJR56388 HDJR56389 HDJR56390 HDJR56391 HDJR56666 HDJN50977 HDJN50978 HDJQ53071 HDJM51282 HDJM51283 HDJM51284 HDJM51285 HDJM51286 HDJM51287 HDJM51288 HDJM51289 HDJM51290 HDJM51291 HDJM51292 HDJM51293 HDJM51294 HDJM51295 HDJQ50845 HDJQ50846 HDJQ50361 HDJQ50362 HDJQ50363 HDJQ50364 HDJQ50365 HDJQ52097 HDJM51403 HDJM51871 HDJP52195 HDJP52198 HDJP52199 HDJP52200 HDJP52201 HDJP52202 HDJP52203 HDJP52204 HDJP52205 HDJP52206 HDJP52207 HDJM50831 HDJM50832 HDJM50833 HDJS51808 HDJM50053 HDJM50054 HDJM50098 HDJM50099 HDJM50101 HDJM50103 HDJM50105 HDJM50124 HDJP50315 HDJP50369 HDJP50371 HDJR58044 HDJR58045 HDJP51614 HDJP51615 HDJN52372 HDJN52373 HDJS50504 HDJS50505 HDJM50027 HDJL50483 HDJM50022 HDJM50024 HDJM50411 HDJS50708 HDJS52037 HDJR57284 HDJR57285 HDJN52002 HDJN50436 HDJN50437 HDJP50552 HDJP50553 HDJQ50808 HDJP50078 HDJP50083 HDJQ52336 HDJQ52337 HDJQ52036 HDJQ52037 HDJQ52038 HDJQ52039 HDJS51666 HDJP52689 HDJQ51784 HDJQ51785 HDJQ51786 HDJQ51787 HDJS50825 HDJS50826 HDJS50827 HDJS50828 HDJS50829 HDJS50830 HDJS50831 HDJS50832 HDJR56841 HDJR56842 HDJR56843 HDJR56844 HDJR56845 HDJR56846 HDJR56847 HDJR56848 HDJR56849 HDJR56850 HDJR56851 HDJR56852 HDJR56853 HDJS51131 HDJQ52031 HDJQ50663 HDJS50931 HDJS50932 HDJQ51956 HDJM50250 HDJM50251 HDJM50252 HDJM50253 HDJM50254 HDJM50255 HDJM52126 HDJM52127 HDJM52128 HDJM52129 HDJQ50066 HDJQ50067 HDJR50762 HDJR50763 HDJR50764 HDJR58093 HDJR58094 HDJR58095 HDJR52011 HDJR52012 HDJR54180 HDJR50307 HDJR50308 HDJR50309 HDJR50310 HDJS51721 HDJM51686 HDJM51687 HDJN51900 HDJN51901 HDJP51716 HDJS50570 HDJS50571 HDJS50572 HDJS50573 HDJM50391 HDJM50392 HDJP50523 HDJP50524 HDJP50525 HDJP50526 HDJP50527 HDJP50528 HDJL50044 HDJP50572 HDJP52345 HDJP52349 HDJP52350 HDJQ52153 HDJQ52154 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HDJS50964 HDJS50966 HDJS50967 HDJS50968 HDJS50970 HDJS50971 HDJS50973 HDJS50974 HDJS51282 HDJS51065 HDJS51066 HDJR50475 HDJR50476 HDJP52208 HDJR57684 HDJS51257 HDJQ52834 HDJQ52842 HDJQ52945 HDJQ52946 HDJQ52947 HDJQ52948 HDJQ52949 HDJQ52950 HDJQ52951 HDJQ52952 HDJQ52953 HDJQ52954 HDJQ52955 HDJM50245 HDJQ52831 HDJQ52832 HDJR50479 HDJN51500 HDJP50596 HDJQ50093 HDJQ50094 HDJQ50095 HDJQ50096 HDJR50200 HDJR56721 HDJR56787 HDJR56788 HDJR56789 HDJR56793 HDJR58250 HDJS50212 HDJS50216 HDJS50217 HDJS50225 HDJS50229 HDJS50230 HDJR58175 HDJR58237 HDJR58238 HDJR58239 HDJR58240 HDJR58241 HDJR58171 HDJL50408 HDJL50412 HDJL50413 HDJL50414 HDJL50415 HDJL50416 HDJL50417 HDJL50419 HDJL50420 HDJL50421 HDJL50403 HDJL50404 HDJL50405 HDJL50406 HDJL50407 HDJL50409 HDJL50410 HDJL50411 HDJL50418 HDJQ52200 HDJS50497 HDJQ52151 HDJQ52152 HDJR57221 HDJR57317 HDJR57442 HDJR58145 HDJQ53081 HDJS52526 HDJN50907 HDJN50908 HDJN50910 HDJN50911 HDJN50918 HDJS50726 HDJS50727 HDJS50728 HDJN51732 HDJP51580 HDJP51581 HDJP51582 HDJP51583 HDJP51616 HDJP51617 HDJP51618 HDJP51619 HDJP51620 HDJR56693 HDJR56729 HDJR56730 HDJR56732 HDJR56737 HDJQ51164 HDJQ51165 HDJQ51166 HDJQ51167 HDJQ51168 HDJR56892 HDJR56894 HDJP51576 HDJQ51968 HDJQ52041 HDJQ52042 HDJQ52044 HDJQ52045 HDJQ52046 HDJQ52047 HDJQ52059 HDJR50634 HDJN50355 HDJN50356 HDJQ51305 HDJQ51233 HDJQ51830 HDJQ51831 HDJQ52693 HDJQ52694 HDJQ52695 HDJQ52696 HDJQ52697 HDJQ52698 HDJQ52699 HDJQ52700 HDJQ52701 HDJM51337 HDJM51338 HDJM52283 HDJN50096 HDJN50097 HDJN50098 HDJN50099 HDJN50100 HDJN50427 HDJN50428 HDJN50429 HDJN50430 HDJN50432 HDJN50433 HDJN50434 HDJN50351 HDJN50352 HDJN50418 HDJN50421 HDJN50422 HDJN50423 HDJN50425 HDJN50426 HDJN51289 HDJN51291 HDJN51292 HDJN51293 HDJN51294 HDJN51680 HDJN51681 HDJP50034 HDJP50036 HDJP50158 HDJP50803 HDJP50804 HDJP50805 HDJP50806 HDJP50809 HDJP50812 HDJP50813 HDJP52491 HDJP52493 HDJP52348 HDJQ50738 HDJR56733 HDJR56728 HDJR56912 HDJR57368 HDJP51395 HDJP51396 HDJP52494 HDJR57163 HDJR57410 HDJR50795 HDJR50796 HDJR50797 HDJS50213 HDJS50214 HDJS50215 HDJS50218 HDJS50219 HDJS50220 HDJS50221 HDJS50223 HDJS50224 HDJN50242 HDJN50250 HDJN50251 HDJN50243 HDJN50244 HDJN50245 HDJN50246 HDJN50247 HDJN50248 HDJN50249 HDJN50252 HDJN50253 HDJN50254 HDJN50255 HDJS52635 HDJS52636 HDJS52637 HDJS52638 HDJS52639 HDJS52640 HDJS52641 HDJS52642 HDJS52643 HDJS52644 HDJS52645 HDJS52646 HDJS52647 HDJN51525 HDJR58249 HDJP52128 HDJP52129 HDJQ51088 HDJQ51089 HDJP52776 HDJM51867 HDJP52759 HDJP52760 HDJP52761 HDJP52774 HDJP52779 HDJN51902 HDJN51903 HDJN51905 HDJN51906 HDJN51984 HDJN51986 HDJN51996 HDJM50361 HDJM50362 HDJM50363 HDJM50364 HDJM50365 HDJM50366 HDJM50367 HDJM50368 HDJM50369 HDJM50370 HDJM50372 HDJM50373 HDJM50374 HDJM50375 HDJM50376 HDJM50378 HDJM50379 HDJM50380 HDJM50381 HDJM50382 HDJM50383 HDJM50384 HDJQ50746 HDJQ50747 HDJM50371 HDJM50377 HDJM51774 HDJM51775 HDJP50549 HDJN51374 HDJN51375 HDJN51376 HDJN51377 HDJN51378 HDJN51379 HDJN51380 HDJS51538 HDJS51147 HDJS51288 HDJS51289 HDJQ53072 HDJM51395 HDJN51787 HDJS51326 HDJS51327 HDJS51328 HDJQ51130…
Recall started: Dec. 12, 2013
Device type: Warmer, Infant Radiant
Root cause (FDA): Process control
What the company told customers: GE Healthcare notified end users with a letter flagged as Urgent Medical Device Correction letter on 12/12/2013. The notification advised that GE Healthcare has become aware of a potential safety issue associated with the loosening of the blender knob shaft on all Resuscitation units. The firm advised that accounts ensure that all potential users in their facility are made aware of this safety notification and the recommended actions described in the notification: 1. Perform blender accuracy check as outlined in Section 2.5-2.5.1 of the Service Manual to verify that the O2 concentration set at 21% is within 16-26% O2 and the concentration at 100% setting is within the recommended range (95-105% O2). 2. If the blender accuracy test results do not meet specifications, remove the unit from patient use and contact a GE Healthcare Service Representative at the number listed below. 3. If the blender accuracy check passes in Step 1 above, you may continue to use your resuscitation system. The following precautions are recommended to ensure blender accuracy is maintained between system checks. Use an independent oxygen analyzer, as determined by your hospital policy, to check blended Air/O2 accuracy. When delivering Oxygen, use a pulse oximeter to monitor your patient. Customers were requested to contact a GE Healthcare Service Representative at 1-800-345-2700 to arrange for correction if the device is found to be defective.
Recall number: Z-0913-2014

Stand-Alone Resuscitation Unit…

Product: Stand-Alone Resuscitation Unit, Bag and Mask, part number M1226444, labeled in part ***GE Healthcare 8880 Gorman Road Laurel, MD 20723***www.gehealthcare.com***. Provides the basic equipment required for pulmonary resuscitation of infants.
Quantity: 15 units
Codes and lots: Serial Numbers: QABS50026 QABR50066 QABR50068 QABR50133 QABS50023 QABR50102 QABR50103 QABR50064 QABR50065 QABR50067 QABS50070 QABS50069 QABR50275 QABS50027 QABR50274
Recall started: Dec. 12, 2013
Device type: Ventilator, Emergency, Manual (Resuscitator)
Root cause (FDA): Process control
What the company told customers: GE Healthcare notified end users with a letter flagged as Urgent Medical Device Correction letter on 12/12/2013. The notification advised that GE Healthcare has become aware of a potential safety issue associated with the loosening of the blender knob shaft on all Resuscitation units. The firm advised that accounts ensure that all potential users in their facility are made aware of this safety notification and the recommended actions described in the notification: 1. Perform blender accuracy check as outlined in Section 2.5-2.5.1 of the Service Manual to verify that the O2 concentration set at 21% is within 16-26% O2 and the concentration at 100% setting is within the recommended range (95-105% O2). 2. If the blender accuracy test results do not meet specifications, remove the unit from patient use and contact a GE Healthcare Service Representative at the number listed below. 3. If the blender accuracy check passes in Step 1 above, you may continue to use your resuscitation system. The following precautions are recommended to ensure blender accuracy is maintained between system checks. Use an independent oxygen analyzer, as determined by your hospital policy, to check blended Air/O2 accuracy. When delivering Oxygen, use a pulse oximeter to monitor your patient. Customers were requested to contact a GE Healthcare Service Representative at 1-800-345-2700 to arrange for correction if the device is found to be defective.
Recall number: Z-0914-2014

Stand-Alone Resuscitation Unit…

Product: Stand-Alone Resuscitation Unit, Bag and Mask, Upgrade Kits, part number M1139612, labeled in part ***GE Healthcare 8880 Gorman Road Laurel, MD 20723***www.gehealthcare.com*** Provides the basic equipment required for pulmonary resuscitation of infant.s
Quantity: 48 units
Codes and lots: Serial Numbers: 402055 402149 402151 402155 402168 402172 402134 401758 401759 401760 401761 401762 401767 401769 401772 401775 401776 401825 401773 401777 401771 401774 401778 401766 401763 401764 401765 401768 401770 400802 400657 400434 400768 401203 401208 402081 402245 402180 401965 400493 400504 400506 401998 402345 402352 400311 401481 410773
Recall started: Dec. 12, 2013
Device type: Ventilator, Emergency, Manual (Resuscitator)
Root cause (FDA): Process control
What the company told customers: GE Healthcare notified end users with a letter flagged as Urgent Medical Device Correction letter on 12/12/2013. The notification advised that GE Healthcare has become aware of a potential safety issue associated with the loosening of the blender knob shaft on all Resuscitation units. The firm advised that accounts ensure that all potential users in their facility are made aware of this safety notification and the recommended actions described in the notification: 1. Perform blender accuracy check as outlined in Section 2.5-2.5.1 of the Service Manual to verify that the O2 concentration set at 21% is within 16-26% O2 and the concentration at 100% setting is within the recommended range (95-105% O2). 2. If the blender accuracy test results do not meet specifications, remove the unit from patient use and contact a GE Healthcare Service Representative at the number listed below. 3. If the blender accuracy check passes in Step 1 above, you may continue to use your resuscitation system. The following precautions are recommended to ensure blender accuracy is maintained between system checks. Use an independent oxygen analyzer, as determined by your hospital policy, to check blended Air/O2 accuracy. When delivering Oxygen, use a pulse oximeter to monitor your patient. Customers were requested to contact a GE Healthcare Service Representative at 1-800-345-2700 to arrange for correction if the device is found to be defective.
Recall number: Z-0915-2014

Stand-Alone Resuscitation…

Product: Stand-Alone Resuscitation, T-Piece, part numbers 2063771-001, 2063772-001, 2063773-001, 2063774-001, 2063775-001, M1226442, M1241420, M1241421, M1241424, M1241425, M1241427, M1241430, M1241461, M1241463, M1241464, and M1241589; labeled in part ***GE Healthcare 8880 Gorman Road Laurel, MD 20723 ***www.gehealthcare.com*** Provides the basic equipment required for pulmonary resuscitation of infants.
Quantity: 375 units
Codes and lots: Serial Numbers: QABR50001 QABR50002 QABR50003 QABR50004 QABR50005 QABR50006 QABR50007 QABR50008 QABR50009 QABR50010 QABR50011 QABR50012 QABR50013 QABR50014 QABR50015 QABR50016 QABR50017 QABR50018 QABR50019 QABR50020 QABR50021 QABR50022 QABR50023 QABR50024 QABR50025 QABR50026 QABR50027 QABR50028 QABR50029 QABR50030 QABR50031 QABR50032 QABR50033 QABR50034 QABR50035 QABR50036 QABR50037 QABR50038 QABR50039 QABR50040 QABR50041 QABR50042 QABR50043 QABR50044 QABR50045 QABR50046 QABR50047 QABR50048 QABR50049 QABR50050 QABR50051 QABR50052 QABR50053 QABR50054 QABR50055 QABR50056 QABR50057 QABR50058 QABR50059 QABR50060 QABR50061 QABR50062 QABR50063 QABR50077 QABR50078 QABR50079 QABR50080 QABR50081 QABR50082 QABR50083 QABR50084 QABR50085 QABR50093 QABR50094 QABR50095 QABR50096 QABR50097 QABR50098 QABR50099 QABR50109 QABR50110 QABR50111 QABR50112 QABR50113 QABR50114 QABR50115 QABR50120 QABR50121 QABR50124 QABR50125 QABR50127 QABR50128 QABR50129 QABR50130 QABR50131 QABR50134 QABR50135 QABR50136 QABR50137 QABR50138 QABR50139 QABR50140 QABR50141 QABR50142 QABR50143 QABR50144 QABR50145 QABR50146 QABR50147 QABR50148 QABR50149 QABR50150 QABR50151 QABR50152 QABR50153 QABR50154 QABR50155 QABR50156 QABR50157 QABR50158 QABR50159 QABR50160 QABR50161 QABR50162 QABR50163 QABR50164 QABR50165 QABR50166 QABR50167 QABR50168 QABR50169 QABR50170 QABR50171 QABR50172 QABR50173 QABR50174 QABR50175 QABR50176 QABR50177 QABR50178 QABR50179 QABR50180 QABR50181 QABR50182 QABR50183 QABR50184 QABR50185 QABR50186 QABR50187 QABR50188 QABR50189 QABR50190 QABR50191 QABR50192 QABR50193 QABR50194 QABR50195 QABR50196 QABR50197 QABR50198 QABR50199 QABR50200 QABR50201 QABR50202 QABR50203 QABR50204 QABR50205 QABR50207 QABR50208 QABR50209 QABR50210 QABR50211 QABR50212 QABR50213 QABR50214 QABR50215 QABR50216 QABR50217 QABR50218 QABR50219 QABR50220 QABR50221 QABR50222 QABR50223 QABR50224 QABR50225 QABR50226 QABR50227 QABR50228 QABR50229 QABR50231 QABR50232 QABR50233 QABR50234 QABR50235 QABR50236 QABR50237 QABR50238 QABR50239 QABR50240 QABR50241 QABR50242 QABR50243 QABR50244 QABR50245 QABR50246 QABR50247 QABR50248 QABR50249 QABR50250 QABR50251 QABR50252 QABR50253 QABR50254 QABR50255 QABR50256 QABR50257 QABR50258 QABR50259 QABR50260 QABR50261 QABR50262 QABR50263 QABR50264 QABR50265 QABR50266 QABR50267 QABR50268 QABR50269 QABR50270 QABR50271 QABR50272 QABR50273 QABS50001 QABS50002 QABS50003 QABS50004 QABS50005 QABS50006 QABS50007 QABS50008 QABS50009 QABS50010 QABS50011 QABS50012 QABS50013 QABS50014 QABS50015 QABS50016 QABS50017 QABS50018 QABS50019 QABS50020 QABS50022 QABS50024 QABS50025 QABS50028 QABS50029 QABS50030 QABS50031 QABS50032 QABS50033 QABS50034 QABS50035 QABS50036 QABS50037 QABS50038 QABS50039 QABS50040 QABS50041 QABS50042 QABS50043 QABS50044 QABS50045 QABS50046 QABS50047 QABS50048 QABS50049 QABS50050 QABS50051 QABS50052 QABS50053 QABS50055 QABS50056 QABS50057 QABS50058 QABS50059 QABS50060 QABS50061 QABS50062 QABS50063 QABS50064 QABS50065 QABS50066 QABS50067 QABS50068 QABS50071 QABS50072 QABS50073 QABS50074 QABS50075 QABS50076 QABS50077 QABS50078 QABS50079 QABS50080 QABS50081 QABS50082 QABS50083 QABS50084 QABS50085 QABS50087 QABS50088 QABS50089 QABS50090 QABS50091 QABS50092 QABS50093 QABS50094 QABS50095 QABS50096 QABS50097 QABS50098 QABS50099 QABS50100 QABS50101 QABS50104 QABS50105 QABS50106 QABS50107 QABS50108 QABS50109 QABS50110 QABS50111 QABS50112 QABS50113 QABS50114 QABS50117 QABS50118 QABS50119 QABS50120 QABS50121 QABS50122 QABS50123 QABS50124 QABS50125 QABS50126 QABS50127 QABS50128 QABS50129 QABS50130 QABS50131 QABS50132 QABS50133 QABS50134 QABS50135 QABS50136 QABS50137 QABS50138 QABS50139 QABS50140 QABS50141 QABS50142 QABS50143 QABS50144 QABS50145 QABS50147 QABS50148 QABS50149 QABS50150 QABS50151 QABS50152 QABS50153 QABS50154 QABS50160
Recall started: Dec. 12, 2013
Device type: Ventilator, Emergency, Powered (Resuscitator)
Root cause (FDA): Process control
What the company told customers: GE Healthcare notified end users with a letter flagged as Urgent Medical Device Correction letter on 12/12/2013. The notification advised that GE Healthcare has become aware of a potential safety issue associated with the loosening of the blender knob shaft on all Resuscitation units. The firm advised that accounts ensure that all potential users in their facility are made aware of this safety notification and the recommended actions described in the notification: 1. Perform blender accuracy check as outlined in Section 2.5-2.5.1 of the Service Manual to verify that the O2 concentration set at 21% is within 16-26% O2 and the concentration at 100% setting is within the recommended range (95-105% O2). 2. If the blender accuracy test results do not meet specifications, remove the unit from patient use and contact a GE Healthcare Service Representative at the number listed below. 3. If the blender accuracy check passes in Step 1 above, you may continue to use your resuscitation system. The following precautions are recommended to ensure blender accuracy is maintained between system checks. Use an independent oxygen analyzer, as determined by your hospital policy, to check blended Air/O2 accuracy. When delivering Oxygen, use a pulse oximeter to monitor your patient. Customers were requested to contact a GE Healthcare Service Representative at 1-800-345-2700 to arrange for correction if the device is found to be defective.
Recall number: Z-0916-2014

Upgrade Kit…

Product: Upgrade Kit, Resuscitation, T-Piece, part numbers M1139417, M1192226 and M1223628, labeled in part ***GE Healthcare 8880 Gorman Road Laurel, MD 20723 ***www.gehealthcare.com*** Provides the basic equipment required for pulmonary resuscitation of infants.
Quantity: 561 units
Codes and lots: Serial Numbers: 100341 100342 100348 200118 200143 200513 200522 200590 200598 200617 201111 201375 201384 201409 201424 201567 201621 201622 201625 201627 201814 202013 202021 202141 202143 202147 202280 202300 202365 202395 202439 202538 203117 203186 203419 203448 203452 203453 203755 203961 204048 204153 204154 204166 204170 204323 204333 204732 204848 204858 204882 204888 204896 204898 204904 204906 204908 205060 205062 205074 205076 205077 205078 205079 205095 205096 205098 205101 205105 205106 205110 205114 205115 205118 205121 205124 205129 205131 205132 205133 205134 205135 205136 205137 205139 205140 205141 205142 205143 205144 205145 205146 205147 205148 205150 205151 205152 205164 205169 205233 205238 205239 205285 205324 205326 205328 205331 205341 205355 205380 205461 205475 205481 205531 205547 205557 205561 205628 205629 205630 205632 205635 205699 205832 205836 205848 205849 205850 205856 205861 205863 205866 205875 205922 205925 205939 205942 205944 205949 205952 205961 205990 206006 206026 206033 206035 206036 206059 206068 206101 206105 206116 206118 206123 206124 206126 206128 206129 206130 206135 206144 206153 206158 206160 206165 206180 206183 206203 206206 206208 206210 206236 206239 206248 206250 206255 206259 206278 206279 206282 206293 206304 206312 206313 206314 206315 206317 206318 206319 206320 206322 206323 206324 206327 206328 206329 206330 206331 206332 206334 206335 206337 206341 206343 206357 206379 206380 206381 206382 206383 206385 206386 206387 206388 206389 206390 206391 206392 206393 206395 206396 206399 206400 206403 206408 206412 206420 206422 206425 206428 206430 206457 206463 206476 206512 206519 206523 206579 206581 206624 206634 206636 206639 206640 206641 206642 206645 206648 206650 206651 206652 206653 206656 206658 206659 206660 206661 206662 206665 206666 206669 206670 206679 206682 206685 206687 206693 206827 206944 206955 206961 206966 207025 207031 207034 207277 207278 207279 207280 207281 207287 207289 207385 207386 207395 207403 207405 207409 207412 207417 207419 207431 207437 207440 207445 207446 207447 207448 207454 207456 207458 207459 207460 207462 207463 207466 207468 207469 207470 207472 207473 207475 207476 207481 207482 207483 207485 207486 207516 207524 207526 207535 207539 207540 207542 207543 207544 207550 207551 207552 207559 207676 207771 207773 207778 207779 207781 207784 207785 207788 207789 207791 207792 207793 207794 207795 207839 207842 207857 207858 207859 207872 207877 207878 207882 207883 207888 207891 207893 207894 207895 207897 207905 207920 207946 208088 208113 208119 208120 208121 208122 208129 208130 208131 208133 208135 208149 208157 208158 208161 208163 208167 208168 208173 208184 208205 208216 208224 208358 208365 208371 208372 208377 208378 208379 208381 208382 208383 208384 208385 208386 208387 208388 208389 208390 208391 208394 208396 208441 208449 208451 208456 208460 208464 208466 208470 208472 208475 208480 208484 208485 208487 208488 208490 208491 208493 208542 208543 208545 208549 208550 208552 208554 208558 208561 208563 208586 208589 208590 208596 208597 208598 208600 208601 208602 208603 208607 208608 208609 208610 208613 208667 208673 208677 208682 208683 208685 208687 208690 208694 208699 208712 208713 208714 208715 208716 208723 208725 208726 208727 208728 208729 208732 208734 208736 208738 208740 208742 208743 208750 208751 208753 208755 208757 208783 208784 208785 208786 208787 208788 208793 208795 208798 208801 208805 208808 208810 208812 208813 208815 208816 208817 208818 208819 208820 208822 208823 208825 208826 208827 208834 208838 208839 208841 208856 208857 208859 208860 208861 208862 208864 208920 209000 209002 209013 209088 209095 209097 209098 209215 209216 209225 209226 209236 209359 209383 209391 209398 209399 209551 209557 209559 209560 209563 209567 209572 209588 209706 209788 209799 209803 209804 209806 209808 209813 401192 401427 401871 454895 493669 5296593
Recall started: Dec. 12, 2013
Device type: Ventilator, Emergency, Powered (Resuscitator)
Root cause (FDA): Process control
What the company told customers: GE Healthcare notified end users with a letter flagged as Urgent Medical Device Correction letter on 12/12/2013. The notification advised that GE Healthcare has become aware of a potential safety issue associated with the loosening of the blender knob shaft on all Resuscitation units. The firm advised that accounts ensure that all potential users in their facility are made aware of this safety notification and the recommended actions described in the notification: 1. Perform blender accuracy check as outlined in Section 2.5-2.5.1 of the Service Manual to verify that the O2 concentration set at 21% is within 16-26% O2 and the concentration at 100% setting is within the recommended range (95-105% O2). 2. If the blender accuracy test results do not meet specifications, remove the unit from patient use and contact a GE Healthcare Service Representative at the number listed below. 3. If the blender accuracy check passes in Step 1 above, you may continue to use your resuscitation system. The following precautions are recommended to ensure blender accuracy is maintained between system checks. Use an independent oxygen analyzer, as determined by your hospital policy, to check blended Air/O2 accuracy. When delivering Oxygen, use a pulse oximeter to monitor your patient. Customers were requested to contact a GE Healthcare Service Representative at 1-800-345-2700 to arrange for correction if the device is found to be defective.
Recall number: Z-0917-2014

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement reports, recall numbers Z-0912-2014, Z-0913-2014, Z-0914-2014, Z-0915-2014, Z-0916-2014, Z-0917-2014. The agency record governs; check it and the company before acting.

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