Infant Warmer System (IWS)

Date

June 21, 2017

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Terminated

Filed by

GE Healthcare, LLC

Product

Infant Warmer System (IWS)

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.

Distribution pattern

Worldwide Distribution - USA (nationwide) Distribution.

Quantity

34986

Codes and lots

Medical device listing number: D103053, D103054, D103056, D103057, D183529

Recall started

May 5, 2017

Device type

Warmer, Infant Radiant

Root cause (FDA)

Under Investigation by firm

What the company told customers

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.

Recall number

Z-2323-2017

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-2323-2017. The agency record governs; check it and the company before acting.