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U.S. Department of Health and Human Services

Class 2 Device Recall Infant Warmer System (IWS)

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  Class 2 Device Recall Infant Warmer System (IWS) see related information
Date Initiated by Firm August 04, 2016
Create Date January 11, 2017
Recall Status1 Terminated 3 on July 12, 2018
Recall Number Z-1015-2017
Recall Event ID 75210
510(K)Number K963058  
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
262-513-4122
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		 Use error
Action This recall strategy includes the depth of the recall, plan for public warning and effectiveness check. The strategy outlined below addresses these elements for this particular recall. The plan for public warning is to contact all customers with potentially affected product by means of an Urgent Medical Device Correction letter. The letter will instruct customers that they can continue to use the device by following instructions on the Addendum to the Service Manual. The Service Manual Addendum provides instructions for checking and tightening the screws. In the US the letter will be sent by a traceable means [either US Postal Service with receipt acknowledgement (registered mail) or equivalent courier service such as FEDEX]. This letter will be sent to: Nurse Manager, Labor & Delivery/NICU; Manager, Bio-Medical Engineering; and Director of Risk Management.
Quantity in Commerce 32,073 (US = 24,361; OUS = 7,712)
Distribution This product has been distributed domestically and internationally .
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 = OHMEDA MEDICAL
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