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Recall Observatory FDA recall evidence

Device product

Infant Warmer System (IWS)

Z-1015-2017

August 04, 2016

Class II

Product summary

Firm
GE Healthcare, LLC
Event
Event 75210
Status
Terminated
Classification
Class II
Quantity
32,073 (US = 24,361; OUS = 7,712)
Official record key
device-enforcement:Z-1015-2017

Official wording

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.

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

Distribution pattern: This product has been distributed domestically and internationally .

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.