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U.S. Department of Health and Human Services

Class 2 Device Recall GE Healthcare

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 Class 2 Device Recall GE Healthcaresee related information
Date Initiated by FirmAugust 09, 2024
Date PostedSeptember 20, 2024
Recall Status1 Open3, Classified
Recall NumberZ-3080-2024
Recall Event ID 95216
510(K)NumberK201628 
Product Classification Warmer, infant radiant - Product Code FMT
ProductGE Giraffe Warmer, Model/Catalog Number M1118179-01090979. Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's transition to the external environment or to provide a controlled open environment.
Code Information Serial Number GBW24230381SA
Recalling Firm/
Manufacturer		 Wipro GE Healthcare Private Ltd.
122 Part 1
Odyssey And Galileo
Bengaluru India
For Additional Information ContactGE HealthCare Service
800-437-1171
Manufacturer Reason
for Recall		GE HealthCare has become aware that complete electrical safety testing was not conducted during manufacturing of certain Giraffe and Panda iRes Warmers. There are multiple electrical safety protections included in the product design. However, because the electrical safety testing in manufacturing was incomplete for these devices, there is the potential for leakage current to exceed IEC 60601 limits.
FDA Determined
Cause 2		Process control
ActionGE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 08/09/2024 by letter disseminated through a traceable means. The notice explained the safety issue and the potential for adverse impact to user or patient. The notice also provided information for the safe operation of the device until GE Healthcare is able to inspect and test the units. A GE Healthcare representative will contact the consignee to arrange for the correction. Questions: Contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.
Quantity in Commerce1
DistributionUS and Australia, Denmark, France, Germany, Ireland, ITALY, New Zealand, Poland, Portugal, Slovenia, Spain, SWITZERLAND, United Arab Emirates, United Kingdom.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = FMT
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