Panda iRes and Giraffe Infant Warmers…

Date posted by the FDA

Sept. 11, 2008

Status

Terminated

Filed by

Datex Ohmeda, Inc. dba GE Healthcare

Product

Panda iRes and Giraffe Infant Warmers, labeled in part*** GE Healthcare 8880 Gorman Road Laurel, MD 20723 U.S.A. www.gehealthcare.com*** Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology.

Reason

Medical device software may be subject to signal interference of the Hands Free Alarm Silence feature that could impact patient safety.

Distribution pattern

The medical devices were distributed to hospitals nationwide.

Quantity

639 devices

Codes and lots

HDJL50229 HDJL50230 HDJL50231 HDJL50232 HDJM50087 HDJM50085 HDJL50290 HDJL50291 HDJL50292 HDJL50293 HDJL50512 HDJL50513 HDJL50514 HDJL50515 HDJL50516 HDJM50199 HDJM50200 HDJM50201 HDJL50279 HDJL50285 HDJL50496 HDJL50497 HDJL50498 HDJL50499 HDJL50500 HDJL50501 HDJL50502 HDJL50503 HDJL50504 HDJM50203 HDJL50256 HDJL50257 HDJL50327 HDJL50543 HDJL50539 HDJM50066 HDJM50067 HDJM50068 HDJM50008 HDJM50009 HDJM50010 HDJM50011 HDJL50489 HDJL50490 HDJL50492 HDJL50518 HDJL50519 HDJL50520 HDJM50088 HDJM50089 HDJM50090 HDJM50091 HDJL50233 HDJL50234 HDJL50235 HDJL50236 HDJL50190 HDJL50191 HDJL50192 HDJL50193 HDJL50194 HDJL50384 HDJL50385 HDJL50386 HDJL50387 HDJL50388 HDJL50389 HDJL50390 HDJL50391 HDJL50397 HDJL50398 HDJL50399 HDJL50400 HDJL50488 HDJL50491 HDJL50493 HDJL50494 HDJL50517 HDJL50521 HDJL50522 HDJL50523 HDJL50289 HDJM50069 HDJM50070 HDJL50457 HDJL50538 HDJL50472 HDJL50428 HDJL50429 HDJL50430 HDJL50432 HDJL50433 HDJL50434 HDJL50435 HDJL50364 HDJL50485 HDJL50318 HDJL50319 HDJL50320 HDJL50321 HDJL50322 HDJL50323 HDJL50324 HDJL50401 HDJL50402 HDJM50012 HDJL50311 HDJL50312 HDJL50313 HDJL50314 HDJL50478 HDJL50462 HDJL50463 HDJL50464 HDJL50380 HDJL50381 HDJL50524 HDJL50525 HDJL50526 HDJL50527 HDJL50270 HDJL50271 HDJM50016 HDJM50017 HDJM50018 HDJM50071 HDJL50540 HDJL50541 HDJM50053 HDJM50054 HDJM50098 HDJM50099 HDJM50101 HDJM50103 HDJM50105 HDJM50124 HDJL50166 HDJL50167 HDJL50168 HDJL50169 HDJL50170 HDJL50171 HDJL50172 HDJL50173 HDJL50174 HDJL50175 HDJL50176 HDJL50177 HDJL50303 HDJL50304 HDJL50305 HDJL50306 HDJL50307 HDJL50308 HDJL50309 HDJL50310 HDJL50466 HDJL50467 HDJL50470 HDJL50471 HDJL50365 HDJL50366 HDJL50367 HDJL50368 HDJL50369 HDJL50370 HDJL50371 HDJL50372 HDJL50373 HDJL50374 HDJL50379 HDJM50030 HDJM50031 HDJM50032 HDJM50033 HDJM50034 HDJM50035 HDJM50036 HDJM50037 HDJM50038 HDJM50039 HDJM50040 HDJM50041 HDJM50042 HDJM50106 HDJM50107 HDJM50126 HDJM50127 HDJM50128 HDJM50129 HDJM50130 HDJM50131 HDJM50132 HDJM50133 HDJM50134 HDJM50135 HDJM50136 HDJM50137 HDJL50254 HDJL50255 HDJM50073 HDJM50074 HDJM50075 HDJM50076 HDJM50077 HDJM50078 HDJM50079 HDJM50080 HDJM50081 HDJM50082 HDJL50461 HDJL50479 HDJL50246 HDJL50247 HDJL50248 HDJL50249 HDJL50250 HDJL50251 HDJL50252 HDJL50253 HDJL50315 HDJL50316 HDJL50300 HDJL50299 HDJL50301 HDJL50195 HDJL50196 HDJL50197 HDJL50198 HDJL50199 HDJL50200 HDJL50201 HDJL50202 HDJL50203 HDJL50204 HDJL50205 HDJL50206 HDJL50207 HDJL50208 HDJL50209 HDJL50210 HDJL50211 HDJL50212 HDJL50213 HDJL50287 HDJL50288 HDJL50473 HDJL50474 HDJL50475 HDJL50476 HDJL50477 HDJL50468 HDJL50469 HDJL50508 HDJL50509 HDJL50510 HDJL50511 HDJM50005 HDJM50006 HDJM50007 HDJL50448 HDJL50456 HDJL50458 HDJL50268 HDJL50269 HDJL50046 HDJL50047 HDJL50048 HDJL50049 HDJL50050 HDJL50051 HDJL50052 HDJL50053 HDJL50054 HDJL50055 HDJL50056 HDJL50057 HDJL50058 HDJL50059 HDJL50060 HDJL50067 HDJL50068 HDJL50069 HDJL50070 HDJL50071 HDJL50072 HDJL50073 HDJL50074 HDJL50075 HDJL50076 HDJL50077 HDJL50078 HDJL50079 HDJL50080 HDJL50081 HDJL50082 HDJL50083 HDJL50084 HDJL50085 HDJL50086…

Recall started

May 20, 2008

Device type

Warmer, Infant Radiant

Root cause (FDA)

Software design

What the company told customers

The recalling firm notified Hospital Administrators, NICU Nursing Manager/Labor & Delivery Nursing Managers and Heads of Biomedical Engineering departments at consignee locations by certified letter on 05/20/08. The notification was flagged as "Urgent Medical Device Correction" and advised consignees of safety issues and recommended actions when using the device. The notification advised that the safest way to mitigate the potential interference issue is to disable the Hands Free Alarm Silence. Users were informed that once a permanent correction action is identified, service representatives will implement the correction. For assistance, contact GE Healthcare at 1-800-345-2700.

Recall number

Z-2227-2008

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

Source: FDA · Medical device enforcement report, recall number Z-2227-2008. The agency record governs; check it and the company before acting.