Recall Z-0481-2019
GE Healthcare, LLC · initiated September 25, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Giraffe Warmer. Device sold under the following product names: Giraffe Warmer and Giraffe Bedded Warmer. infant radiant warmer.
Codes / lots: Model Number, UDI (Serial Number): M1118179-018104, Not Applicable (HDJM50056); M1118179-018118, Not Applicable (HDJM50178); M1118179-024117, Not Applicable (HDJM50583); M1118179-018118, Not Applicable (HDJM50094); M1118179-022861, Not Applicable (HDJR54165); M1118179-020841, Not Applicable (HDJM50142); M1118179-024117, Not Applicable (HDJQ50967); M1118179-024117, Not Applicable (HDJQ50971); M1118179-024117, Not Applicable (HDJQ50973); M1118179-024117, Not Applicable (HDJQ50972); M1118179-024117, Not Applicable (HDJQ50974); M1118179-022643, Not Applicable (HDJM52091); M1118179-018104, Not Applicable (HDJM50060); M1118179-150421, Not Applicable (HDJT51438); M1118179-150421, Not Applicable (HDJT51439); M1118179-022643, Not Applicable (HDJM50696); M1118179-150421, Not Applicable (HDJT51652); M1118179-022643, Not Applicable (HDJQ50385); M1118179-161255, Not Applicable (HDJT60578); M1118179-161255, Not Applicable (HDJT60576); M1118179-161255, Not Applicable (HDJT60572); M1118179-161255, Not Applicable (HDJT60584); M1118179-161255, Not Applicable (HDJT60568); M1118179-026229, Not Applicable (HDJM51309); M1118179-022643, Not Applicable (HDJM50420); M1118179-022643, Not Applicable…
Reason for recall
Potential electric leakage affecting the user.
FDA-determined cause: Process design
Action taken
GE Healthcare notified customers on about 09/25/2018 via URGENT MEDICAL DEVICE CORRECTION letter. The letter indicated that the device could continue to be used along with good clinical practices. GE Healthcare will visit each location to perform the necessary testing. Until GE Healthcare can visit each site, instructions are to disconnect devices that use the USB (Giraffe OmniBed Carestation and Giraffe Incubator Carestation only) and the RS232 Nurse call ports, and inspect all power cords to ensure there is no damage to the cord or ground pin. GE Healtchare will perform necessary electrical safety test on all affected products and correct if required. A GE Healthcare representative will contact each customer to arrange for this test. For questions or concerns, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Details
- Recall number
- Z-0481-2019
- Initiated
- September 25, 2018
- Terminated
- July 13, 2020
- Product code
- FMT – Warmer, Infant Radiant
- Quantity
- 1,724 devices total
- Distribution
- Worldwide distribution. US Nationwide, Algeria, Australia, Austria, Belgium, Canada, Chile, China, Costa Rica, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Honduras, India, Indonesia, Ireland, Italy, Japan, Kazakhstan, Korea, Lithuania, Mexico, Netherlands, New Zealand, Norway, Pakistan, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia…
- Recalling firm
- GE Healthcare, LLC, Waukesha, WI
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0479-2019 Class II | Giraffe OmniBed Carestation. Neonatal incubator. Device sold under the following product…Potential electric leakage affecting the user. | 09/25/2018Terminated |
| Z-0480-2019 Class II | Giraffe Incubator Carestation. Neonatal incubator. Device sold under the following…Potential electric leakage affecting the user. | 09/25/2018Terminated |
| Z-0482-2019 Class II | Panda iRes Infant Radiant Warmer. Device sold under the following product names: Panda…Potential electric leakage affecting the user. | 09/25/2018Terminated |
| Z-0483-2019 Class II | Panda Freestanding Warmer. Device sold under the following product names: Panda…Potential electric leakage affecting the user. | 09/25/2018Terminated |
| Z-0484-2019 Class II | Panda Wall Mount warmer. Infant radiant warmerPotential electric leakage affecting the user. | 09/25/2018Terminated |