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U.S. Department of Health and Human Services

Class 2 Device Recall Infant Radiant Warmer

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  Class 2 Device Recall Infant Radiant Warmer see related information
Date Initiated by Firm May 05, 2017
Date Posted May 19, 2017
Recall Status1 Terminated 3 on July 12, 2018
Recall Number Z-2323-2017
Recall Event ID 77287
510(K)Number K963058  K921766  K884160  K851449  K840858  
Product Classification Warmer, infant radiant - Product Code FMT
Product Infant Warmer System (IWS)
Code Information Medical device listing number: D103053, D103054, D103056, D103057, D183529
Recalling Firm/
Manufacturer		 GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
800-437-1171
Manufacturer Reason
for Recall		 GE Healthcare has recently become aware of a potential safety issue related to loose screws in the Heater Head of the Infant Warmer System (IWS). Hot screws from the Heater Head of the IWS could fall onto the bed if the Heater Head assembly has been improperly serviced. This situation can be clinically hazardous because thermal injury to a patient could result. Two injuries have been reported as a result of this issue.
FDA Determined
Cause 2		 Under Investigation by firm
Action GE Healthcare sent an Urgent Medical Device Correction letter dated May 5, 2017, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Product Correction : Attached to this letter, we provide instructions as part of a Service Manual Addendum on how to correct the issue. Please add this new Addendum to the Service Manual of your device(s) and train the affected users accordingly. Please acknowledge that you have received this letter and that you understand that an action needs to be taken on your part to correct this issue by filling out and returning the attached Customer Response form. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative. Please be assured that maintaining a high level of safety and quality is our highest priority. If you have any questions, please contact us immediately per the contact information above.
Quantity in Commerce 34986
Distribution Worldwide Distribution - USA (nationwide) Distribution.
Total Product Life Cycle TPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FMT and Original Applicant = OHIO MEDICAL PRODUCTS
510(K)s with Product Code = FMT and Original Applicant = OHMEDA MEDICAL
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