GE Healthcare, LLC: Medical Device Recall in 2017 - (Recall #: Z-1015-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

Infant Warmer System (IWS)

Product Classification:

Class II

Date Initiated: August 4, 2016

Date Posted: January 18, 2017

Recall Number: Z-1015-2017

Event ID: 75210

Reason for Recall:

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.

Status: Terminated

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

Code Information:

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

Distribution Pattern:

This product has been distributed domestically and internationally .

Voluntary or Mandated:

Voluntary: Firm initiated