FDA Medical Device Recalls (openFDA)
GE Healthcare, LLC: Infant Warmer System (IWS)
- Recall number
- Z-1015-2017
- Recalling firm
- GE Healthcare, LLC
- Product
- Infant Warmer System (IWS)
- Status
- Terminated
- Initiated
- 2016-08-04
- Posted
- not on file
- Terminated
- 2018-07-12
- Reason
- 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.
- Root cause
- 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
- 32,073 (US = 24,361; OUS = 7,712)
- Distribution
- This product has been distributed domestically and internationally .
- Lot, serial or model codes
- Medical device listing number: D103053, D103054, D103056, D103057, D183529
- 510(k) numbers
- ["K963058"]
- PMA numbers
- not on file
- Product code
- FMT
- Firm FEI
- 2126677
- Firm city
- Waukesha
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28