FDA · Medical device recall

GE Healthcare… and 1 more product

July 9, 2014 Class II

Date: July 9, 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, LLC
Reason: GE Healthcare has become aware of a potential safety issue due to a collimator installation error during a service maintenance activity involving the Proteus XR/a and Revolution XR/d X-ray imaging systems. . There was a reported incident of a collimator fall which caused a serious patient injury.
Distribution pattern: Worldwide Distribution - USA including PR. DC, GUAM, all states except VT. Internationally to the following countries: ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BENIN, BOSNIA AND HERZEGOVINA, BOTSWANA, BRAZIL, BULGARIA, BURKINA FASO, CANADA, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, DOMINICAN REPUBLIC, ECUADOR, EGYPT, ESTONIA, FINLAND, FRANCE, FRENCH POLYNESIA, GERMANY, GREECE, GUATEMALA, HONDURAS, HONG KONG, HUNGRY, ICELAND, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, KAZAKHSTAN, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMHIRIYA, LITHUANIA, MALAYSIA, MALTA, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NICARAGUA, NIGERIA, NORWAY, PAKISTAN, PANAMA, PHILIPPINES, POLAND, PORTUGAL, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SUDAN, SWEDEN, SWITZERLAND, TAIWAN, TANZANIA, THAILAND, TUNISIA, TURKEY, UGANDA, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, VENEZUELA, VIETNAM YEMEN.

2 products in this recall

GE Healthcare…

Product: GE Healthcare, Proteus XR/a. Proteus XR/a Intended Use: Is intended for use in generating radiographic images of human anatomy in all general purpose diagnostic procedures. This device is not intended for mammographic applications.
Quantity: 3460
Codes and lots: Mfg Lot or Serial # System ID 00000023354HL4 804289HDFER 00000017868HL1 801268ER 00000024445HL9 804747DHPER 00000018247HL7 972596PER3 00000021176HL3 804541ER 00000018523HL1 408977ER3 00000019915HL8 772468ER1 00000018898HL7 813571ERPRO 00000018576HL9 850747GCER 00000024536HL5 904391RAD1 00000019171HL8 561395RAD 00000020749HL8 773282TOMO8 00000034015HL8 847316PROER1 00000012567HL4 502868RAD2 00000017199HL1 972596OPRAD1 00000017648HL7 405271UPX1 00000032656HL1 407518PR1 00000041533HL1 580249SPRO2 00000022569HL8 614868PRO4 00000012718HL3 706257SFP 00000020559HL1 770748PER 00000033658HL6 704783PRO1 00000019846HL5 423493ER 00000031607HL5 605342RAD 00000012703HL5 915573RAD1 00000012705HL0 915573RAD2 00000020034HL5 410392R3 00000022299HL2 706554MSR1 00000003188HL2 901722RAD1 00000019209HL6 718780RAD1 00000011073HL4 865425RAD2 00000018254HL3 281338RAD 00000020919HL7 801292RM3 00000041379HL9 580249SPRO 00000038277HL0 408885SVC 00000029264HL9 561863RM6 00000038416HL4 702382XR1 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304624PRT 00000032212HL3 304792PROT1 00000044436HL4 304927R2 00000023082HL1 305295R1 00000041178HL5 305325RM9 00000034576HL9 305345STRAD 00000031033HL4 305682ER1 00000036548HL6 305823ER2 00000016237HL0 307265GERAD 00000042835HL9 307382RAD1 00000034081HL0 307527PROTEUS 00000040966HL4 307634XRA 00000042184HL2 308534NPOXR 00000029991HL7 308928RAD 00000035352HL4 309284XR1 00000015445HL0 309343CR2 00000028486HL9 309454BER 00000058231HL2 309454BX3A 00000034154HL5 309582PROT 00000015195HL1 309655FNCR1 00000015199HL3 309655FNCR2 00000016972HL2 309655FXR6 00000018796HL3 309655MORTON2 00000031034HL2 309662JER 00000029484HL3 309663MHXR1 00000026037HL2 309664CBN2 00000016427HL7 309944HHPROT 00000015856HL8 313359PROT 00000012556HL7 313369PROT 00000036738HL3 313499PROT 00000029439HL7 313640PROT1 00000038206HL9 314251JDRM2 00000045768HL9 314251SJBL 00000045767HL1 314251SJBR 00000037336HL5 314251SJMXR1 00000030698HL5 314344DR6 00000027922HL4 314577CP1 00000019912HL5 314625WER 00000013887HL5 314768MRM8 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00000016796HL5 3271539RAD 00000016751HL0 330332R4 00000043314HL4 330386ER 00000029097HL3 3304382 00000015442HL7 330438R3 00000014306HL5 330489XR3 00000041538HL0 330543XRA 00000040906HL0 330834RAD 00000108822HL8 331551DMGLPROT3 00000023519HL2 332047 00000047158HL1 333PRO 00000046877HL7 334244RAD2 00000022342HL0 334636TRM1 00000033481HL3 336246AMRAD1 00000046734HL0 336719NR140 00000045750HL7 336719NR144 00000010846HL4 336768OSCD 00000010879HL5 336768OSEF 00000010845HL6 336768OSGH 00000022805HL6 336768OSR1 00000046645HL8 337355RAD1 00000038339HL8 337457RAD1 00000034557HL9 337981ER1 00000029190HL6 337981R3 00000033416HL9 337981RAD3 00000080459HL1 33RM4 00000040585HL2 352253RAD1 00000036373HL9 352394RM3 00000023878HL2 352401RAD2 00000015124HL1 352401RAD3 00000029206HL0 352596ERPRO 00000099463HL2 352596PROM 00000045275HL5 352597RAD1 00000032481HL4 360412XR1 00000043297HL1 360414OTHO 00000023757HL8 360414SJOP1 00000012540HL1 360414SJRM4 00000021172HL2 360457ORTHO 00000036280HL6 360493PROT 00000016973HL0 360566RM1 00000028479HL4 360651XR1 00000003535HL2 360754XRM2 00000043001HL7 360992CLK1 00000047153HL2 361275RM1 00000025528HL1 361572CER 00000042524HL9 361698DPR1 00000032653HL8 361857DOR1 00000022340HL4 361980RAP 00000052253HL2 373ORTHO 00000023521HL8 386238FHR1 0000002442OHL2 386238FHR3 00000101039HL6 386326ER 00000028014HL9 386446RM1 00000028855HL5 386446RM2 00000035556HL0 386774RM1 00000034556HL1 386774RM2 00000041537HL2 386FHIRAD 00000043002HL5 386HPORAD 00000032169HL5 386PORAD 00000031204HL1 386TWLRAD 00000016631HL4 401274ER1 00000029101HL3 401431PR1 00000020041HL0 401727P1 00000034920HL9 401766ARP1 00000021678HL8 401782SR1 00000022544HL1 401782SR2 00000029799HL4 401782SR3 00000094369HL6 402393MERAD 00000016794HL0 402481BX3 00000016244HL6 402481LGMX10 00000013775HL2 402481PLRAD 00000032116HL6 402643SMX1 00000020167HL3 402685RAD 00000052993HL3 402745PROT 00000039202HL7 402768RAD1 00000024449HL1 402925RAD 00000030157HL2 402947WRAD 00000037710HL1 404265ER1 00000046411HL5 404265PROT 00000034680HL9 404321PRO1…
Recall started: June 4, 2014
Device type: System, X-Ray, Stationary
Root cause (FDA): Equipment maintenance
What the company told customers: GE Healthcare sent an Urgent Medical Device Correction letter dated June 4, 2014, to all affected consignees. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. For questions in regard to this recall the consignees in the United States were advised to call 800-437-1171. For other countries contact your local GE Healthcare Service Representative. For questions regarding this recall call 800-437-1171.
Recall number: Z-1988-2014

GE Healthcare…

Product: GE Healthcare, Revolution XR/d. Revolution XR/d Intended Use: The Revolution XR/d Digital Radiographic imaging system is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammographic applications.
Quantity: 1053
Codes and lots: Mfg Lot or Serial # System ID 00000000001837 815338WXRD 00000000002821 815759RAD2 00000000003407 205206SWXRD1 00000000001153 205838AXRD1 00000000003535 205939SVER 00000000002574 209669XRD 00000000001745 215481DR19 00000000001320 215481DR21 00000000001315 215481DR2BLAIR 00000000002962 215481XRDER1 00000000003098 251435XRD1 00000000003049 251435XRD2 00000000001366 406496XRD 00000000001380 413447XRD 00000000002377 417347ED1 00000000002584 417451NMC 00000000002257 503GICXRD 00000000002243 505834XRD 00000000002458 516IPKXRD 00000000003171 567661XRD 00000000002865 601443XRD1 00000000002007 606549XRD 00000000002590 618993MDRF 00000000002378 630236XRD 00000000002722 630275ERXRD 00000000002480 630856ER1 00000000003347 708783R8 00000000003524 757886ER 00000000001026 773MTSXRD1 00000000003954 814868RAD 00000000003465 815740XRDER 00000000002414 815933XRD2 00000000002501 847437GEXRD3 00000000003112 850474XRD 00000000002839 850474XRD2 00000000002054 928669XRD 00000000002688 985230RAD4 00000000002869 CLAKEXRD 00000000002488 EBLUFFXRD 00000000004228 505784XRD 00000000004402 843390CON 00000000007854 864560IP3R 00000000003119 210292WHORT 00000000001454 303398XRD 00000000001050 312666VAHUM 00000000001148 312CCHER2 00000000001199 312CCHRAD4 00000000001156 312CCHRAD5 00000000001176 312CCHRAD6 00000000001230 312CCHRAD7 00000000001220 312CCHRAD8 00000000001464 314525SARM8 00000000001193 404321XRD 00000000001357 509942XRD 00000000001087 510372XRD 00000000002395 601264XRD1 00000000002086 605322XRD 00000000001792 605719XRD1 00000000001534 617726XR8Y3 00000000003984 631SLOANXRD 00001126 650493XRD 00000000001091 775786DR01 00000000001760 775885XRD 00000000001075 865545DR2 00000000001368 916366XRD 00000000001089 973971PED1 00000000002124 JAC1D33 00000000001323 JAC1D40 00000000001871 JAC3D13 00000000002239 JAC3E24 00000000002227 JAC3E48 00000000001887 JAC3E53 00000000004024 727893ER1 00000000001274 281338XDER2 00000000001940 509474XRD 00000000002001 415600XRD1 00000000001802 865481DR1 00000000001660 972566XRD1 00000000002675 601288XRD1 00000000001136 281338XD1 00000000001547 678945XRD 00000000001997 864560ER1 00000000001448 2027825A26 00000000003595 203694IC46 00000000001396 205592XRD1 00000000001218 205783PDR2 00000000001458 208737XRD 00000000002481 210646LXRD 00000000001795 212639XRD2 00000000002205 212639XRD3 00000000002560 217258SBER 00000000001666 217876DR8 00000000002296 225358XRD 00000000001621 229312MPXRD 00000000001643 229312MPXRD2 00000000001462 253426XRD1 00000000002000 253426XRD2 00000000022392 256265XR2 00000000002120 269983XRD 00000000002678 303932XRD 00000000001784 310319XRD 00000000001444 310319XRD2 00000000002949 310319XRD3 00000000003542 314251JDRM4 00000000002158 314525AIXRD1 00000000003356 314525AIXRD2 00000000001682 314525SARM5 00000000001580 314569SJCCX1 00000000007286 315449RAD2 00000000001683 317216XRD 0000000000AGA6 318456BRM2 00000000002661 330841XRD7 00000000001849 334293RADER 00000000001720 336713BCC1 00000000001952 336713BCC2 00000000001957 336713BCC4 00000000002125 336716BCR7 00000000001714 404686CRAD8 00000000002404 405271XRD 00000000002470 408236KSXRD2 00000000002564 408236KSXRD3 00000000002363 408236KSXRD7 00000000001318 409772ER2 00000000001853 409899RAD2 00000000003065 410605XRD1 0000FW21530260 412359XRD 00000000001723 415221XRD1 00000000002282 415353XRD1 00000000002502 419483DIGITAL1 00000000001247 423224DR2 00000000001876 423586DR1 00000000002588 503413LEXRD 00000000001874 504447XRD 00000000002462 507437XRD 00000000003045 509946XRD 00000000001375 515226XRD 00000000001413 515241XRD 00000000001710 515241XRD2 00000000002326 516562ERXRD1 00000000002307 518243RM7 00000000001570 518292XRD2 00000000001575 518292XRD3 00000000002427 520574XRD 00000000002889 520TMCXRD 0000000000A885 540332RM1 00000000001200 540332RM5 00000000003258 559325XRD 00000000002793 559459XRD2 00000000002373 570523XRD1 00000000001877 574523ER1 00000000002340 601426XRD1 00000000001057 602239ER2 00000000001635 610770XRD 00000000001178 610954XRD 00000000001830 615327XRD 00000000002800 615338RAD 00000000001831 617340XRD 00000000001675 617726XR1Y6 00000000001204 617726XR3Y3 00000000002189 617726XR5Y3 00000000001834 617726XR7Y3 00000000003920 617732XRD12 00000000001844 617732XRD14 00000000001093 630978XRDE185 00000000001121 631968ERDIG 00000000002099 650497CHXRD1 00000000001868 650497XRD1 00000000002765 702384S05 00000000001326 702855XRD 00000000001211 703696XRD 00000000002328 707442HUMXRD1 00000000001358 708216XRD2 00000000002638 708342XRD 00000000002344 708799XRD 00000000001623 712852XRD 00000000001293 713394ERXRD1 00000000002538 713790MMXRD1 00000000001917 713794ADRA4 00000000001118 713873BTXRD11 00000000001260 715361XRD 00000000001684 718226NORTHER 00000000002871 718240XRD 00000000002311 718901XRD 00000000002520 718963XRD 00000000001271 719867RM11 00000000001442 720225ER 00000000001117 727298ER2 00000000001629 727733RM1 00000000001119 734712CSB1 00000000001352 734712ER1 00000000002818 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FMITR170990019 281338XDER FMITR170990020 314525ARM19A FMITR170990036 713973HDQXI FMITR170990044 ECXR1405B FMITR170990049 210297SLBXRD FMITR170990050 312996UCON FMITR170990051 312996UHUM FMITR170990052 404686CRAD1 FMITR170990053 409899RAD1 FMITR170990055 509473DR3 FMITR170990057 617726XR9Y3 FMITR170990058 650497CHXRD2 FMITR170990059 708425XRD1209 FMITR170990060 727298ER1 FMITR170990061 773967XRD3 FMITR170990062 918744JDR1 FMITR170990063 JAC1D45 FMITR170990064 JESSEBROWNADMIN FMITR170990065 404501DICXRD FMITR170990067 601883XRD FMITR170990128 216844XRD3 FMITR170990129 715833XRD FMITR170990132 415668XRD1 FMITR170990135 615264ER1 FMITR170990153 203576XRD FMITR170990154 409772RS1 FMITR170990160 615896XR2 FMITR170990161 218249XRD1 FMITR170990162 218249XRD2 FMITR170990163 847677DRAD FMITR170990167 205592XRD2 FMITR170990168 205620SXRD1 FMITR170990169 208734IMXRD FMITR170990170 210617H103 FMITR170990171 215710ER1 FMITR170990172 217876ER1 FMITR170990173 225765XRD FMITR170990174 251990XRD FMITR170990175 281929XRD1 FMITR170990176 301698XRD FMITR170990177 303695XRD FMITR170990178…
Recall started: June 4, 2014
Device type: System, X-Ray, Stationary
Root cause (FDA): Equipment maintenance
What the company told customers: GE Healthcare sent an Urgent Medical Device Correction letter dated June 4, 2014, to all affected consignees. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. For questions in regard to this recall the consignees in the United States were advised to call 800-437-1171. For other countries contact your local GE Healthcare Service Representative. For questions regarding this recall call 800-437-1171.
Recall number: Z-1989-2014

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

Source: FDA · Medical device enforcement reports, recall numbers Z-1988-2014, Z-1989-2014. The agency record governs; check it and the company before acting.

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