Recall Z-1015-2017— GE Healthcare, LLC

Name: FDA recall Z-1015-2017
Creator: U.S. Food and Drug Administration
Published: 2016-08-04

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2016-08-04, terminated 2018-07-12. It names one FDA 510(k) clearance: K963058. 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..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Terminated
Initiated: 2016-08-04
Terminated: 2018-07-12
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K963058 — INFANT WARMER SYSTEMOhmeda Medical·cleared 1996-10-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Infant Warmer System (IWS)

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.