—#155625

Product

Infant Warmer System (IWS)

FDA product code: FMT — Warmer, Infant Radiant
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K840858, K851449, K884160, K921766, 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)

Under Investigation by firm

Action the firm took

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.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution - USA (nationwide) Distribution.

Timeline

Recall initiated: 2017-05-05
Posted by FDA: 2017-05-19
Terminated: 2018-07-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #155625. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.