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Terminated

Infant Warmer System (IWS)

FDA Recall Z-2323-2017 · Posted 2017-05-19

Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeFMT
Date Initiated2017-05-05
Date Terminated2018-07-12
Product Quantity34986

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.

Firm Action

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.

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide Distribution - USA (nationwide) Distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K963058INFANT WARMER SYSTEMOhmeda Medical · 1996-10-01K921766OHIO INFANT WARMER SYSTEMOhmeda Medical · 1993-04-23K884160OHMEDA - OHIO(R) 3500 INFANT WARMER SYSTEMOhmeda Medical · 1988-11-21K851449OHMEDA 5000 INFANT WARMER SYSTEMOhmeda Medical · 1985-06-07K840858OHIO 3300 INFANT WARMER SYSTEMOhio Medical Products · 1984-03-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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