• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Panda iRes and Giraffe Infant Warmers

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Recall
Panda iRes and Giraffe Infant Warmers
see related information
Date Posted September 11, 2008
Recall Status1 Open
Recall Number Z-2227-2008
Recall Event ID 48603
Premarket Notification
510(K) Number
K070377 
Product Classification Warmer, Infant Radiant - Product Code FMT
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.
Code Information 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 HDJL50087 HDJL50088 HDJL50089 HDJL50090 HDJL50091 HDJL50092 HDJL50093 HDJL50094 HDJL50095 HDJL50096 HDJL50097 HDJL50098 HDJL50099 HDJL50100 HDJL50101 HDJL50102 HDJL50103 HDJL50104 HDJL50105 HDJL50106 HDJL50107 HDJL50108 HDJL50109 HDJL50110 HDJL50111 HDJL50112 HDJL50113 HDJL50114 HDJL50115 HDJL50116 HDJL50117 HDJL50118 HDJL50119 HDJL50120 HDJL50121 HDJL50122 HDJL50123 HDJL50124 HDJL50125 HDJL50126 HDJL50127 HDJL50128 HDJL50129 HDJL50130 HDJL50131 HDJL50132 HDJL50133 HDJL50134 HDJL50135 HDJL50136 HDJL50137 HDJL50138 HDJL50139 HDJL50140 HDJL50141 HDJL50142 HDJL50143 HDJL50144 HDJL50145 HDJL50146 HDJL50147 HDJL50148 HDJL50149 HDJL50150 HDJL50151 HDJL50152 HDJL50153 HDJL50155 HDJL50156 HDJL50161 HDJL50162 HDJL50163 HDJL50164 HDJL50165 HDJL50237 HDJL50238 HDJL50239 HDJL50241 HDJL50242 HDJL50240 HDJL50243 HDJL50244 HDJL50245 HDJL50403 HDJL50404 HDJL50405 HDJL50406 HDJL50407 HDJL50408 HDJL50409 HDJL50410 HDJL50411 HDJL50412 HDJL50413 HDJL50414 HDJL50415 HDJL50416 HDJL50417 HDJL50418 HDJL50419 HDJL50420 HDJL50421 HDJL50294 HDJL50505 HDJM50083 HDJM50084 HDJL50273 HDJL50274 HDJL50506 HDJL50507 HDJL50295 HDJL50375 HDJL50376 HDJL50377 HDJL50378 HDJL50357 HDJL50358 HDJL50359 HDJL50360 HDJL50362 HDJL50383 HDJM50072 HDJL50317 HDJL50356 HDJL50459 HDJL50460 HDJL50422 HDJL50423 HDJL50226 HDJL50227 HDJL50228 HDJL50443 HDJL50444 HDJL50445 HDJL50446 HDJL50447 HDJM50202 HDJM50204 HDJL50481 HDJL50482 HDJL50483 HDJL50484 HDJM50019 HDJM50020 HDJM50021 HDJM50022 HDJM50023 HDJM50024 HDJM50025 HDJM50026 HDJM50027 HDJM50028 HDJL50363 HDJL50542 HDJL50465 HDJM50003 HDJM50004 HDJM50198 HDJM50092 HDJL50328 HDJL50452 HDJL50453 HDJL50454 HDJL50455 HDJM50206 HDJM50207 HDJL50280 HDJL50281 HDJL50449 HDJL50450 HDJL50451 HDJM50086 HDJL50261 HDJL50262 HDJL50263 HDJL50264 HDJL50265 HDJL50266 HDJL50267 HDJL50278 HDJL50528 HDJL50529 HDJL50530 HDJL50531 HDJL50532 HDJL50533 HDJL50534 HDJL50535 HDJL50536 HDJL50537 HDJL50275 HDJL50276 HDJL50277 HDJL50480 HDJL50258 HDJL50259 HDJL50260 HDJM50095 HDJM50064 HDJM50065 HDJL50214 HDJL50215 HDJL50216 HDJL50217 HDJL50218 HDJL50219 HDJL50220 HDJL50221 HDJL50222 HDJL50223 HDJL50224 HDJL50225 HDJL50296 HDJL50297 HDJL50298 HDJL50272 HDJL50392 HDJL50393 HDJL50394 HDJL50436 HDJL50437 HDJL50438 HDJL50439 HDJL50440 HDJM50013 HDJM50014 HDJM50000 HDJM50001 HDJM50002 HDJM50044 HDJM50043 HDJL50442 HDJL50441 HDJL50286 HDJL50287 HDJL50325 HDJL50326 HDJL50329 HDJL50330 HDJL50424 HDJM50148 HDJM50149 HDJM50150 HDJM50151 HDJM50152 HDJM50153 HDJM50154 HDJM50155 HDJM50156 HDJM50157 HDJM50158 HDJM50159 HDJM50160 HDJM50161 HDJM50162 HDJM50163 HDJM50164 HDJM50165 HDJM50166 HDJM50167 HDJM50168 HDJM50169 HDJM50170 HDJM50171 HDJM50172 HDJM50173 HDJM50174 HDJM50175 HDJM50176 HDJM50177 HDJL50487 HDJM50015 HDJL50018 HDJL50019 HDJL50020 HDJL50021 HDJL50022 HDJL50023 HDJL50024 HDJL50025 HDJL50026 HDJL50027 HDJL50028 HDJL50029 HDJL50030 HDJL50031 HDJL50032 HDJL50033 HDJL50034 HDJL50037 HDJL50038 HDJL50040 HDJL50043 HDJL50044 HDJL50045 HDJL50154 HDJL50178 HDJL50179 HDJL50180 HDJL50181 HDJL50182 HDJL50183 HDJL50184 HDJL50185 HDJL50186 HDJL50187 HDJL50188 HDJL50189 HDJL50431 HDJM50029 HDJM50045 HDJM50046 HDJM50047 HDJM50048 HDJM50049 HDJM50050 HDJM50051 HDJM50052 HDJM50055 HDJM50056 HDJM50057 HDJM50058 HDJM50059 HDJM50060 HDJM50061 HDJM50062 HDJM50093 HDJM50094 HDJM50096 HDJM50097 HDJM50100 HDJM50102 HDJM50104 HDJM50143 HDJM50178 HDJM50179 HDJM50180 HDJL50036 and HDJL50061
Recalling Firm/
Manufacturer
Datex Ohmeda, Inc. dba GE Healthcare
8880 Gorman Rd
Laurel, Maryland 20723-5800
For Additional Information Contact Ann Lebar
414-721-3257
Manufacturer Reason
for Recall
Medical device software may be subject to signal interference of the Hands Free Alarm Silence feature that could impact patient safety.
FDA Determined
Cause 2
DESIGN: Software Design
Action 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.
Quantity in Commerce 639 devices
Distribution The medical devices were distributed to hospitals nationwide.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FMT and Original Applicant = OHMEDA MEDICAL
-
-