—#149672

Product

Infant Warmer System (IWS)

FDA product code: FMT — Warmer, Infant Radiant
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K963058
Affected lot / code info: Medical device listing number: D103053, D103054, D103056, D103057, D183529

Why it was recalled

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 (FDA determination)

Use error

Action the firm took

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.

Recalling firm

Firm: GE Healthcare, LLC
Address: 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

Distribution pattern: This product has been distributed domestically and internationally .

Timeline

Recall initiated: 2016-08-04
Terminated: 2018-07-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #149672. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.