Infant Warmer System (IWS)

Date

Jan. 18, 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

This product has been distributed domestically and internationally .

Quantity

32,073 (US = 24,361; OUS = 7,712)

Codes and lots

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

Recall started

Aug. 4, 2016

Device type

Warmer, Infant Radiant

Root cause (FDA)

Use error

What the company told customers

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.

Recall number

Z-1015-2017

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

Source: FDA · Medical device enforcement report, recall number Z-1015-2017. The agency record governs; check it and the company before acting.