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Terminated

Ohmeda Medical''s Giraffe OmniBeds and Giraffe Incubators

FDA Recall Z-1047-05 · Posted 2005-07-28

Recalling FirmOhmeda Medical, A division of Datex-Ohmeda, Inc.
Recall StatusTerminated
Product CodeFMZ
Date Initiated2005-04-25
Date Terminated2007-01-11
Product Quantity1674 devices

Reason for Recall

Neonatal incubators and beds may unintentionally move from a safe position following an interruption in the power supply.

Firm Action

Ohmeda Medical notified consignees 04/25/05 by letter flagged as an 'Urgent Medical Device Correction'. The serial number specific notification advised that the elevating base may move following the mains power interruption. The letter further advised that the notice should not be confused with a previous (medical device correction) letter sent concerning movement of the elevating base caused by the footswitches on the device. Ohmeda indicated in the letter that users may continue to use the device with stated precautions, pending hardware upgrade by the firm''s service technologists.

Root Cause

Other

Distribution Pattern

The incubators were distributed to hospital neonatal intensive care centers across the US. The devices were additionally distributed to international subsidiaries and distributors.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K020543OHMEDA MEDICAL GIRAFFE OMNIBEDOhmeda Medical · 2002-05-09K020547OHMEDA MEDICAL GIRAFFE INCUBATOROhmeda Medical · 2002-05-09K010222OHMEDA MEDICAL GIRAFFE INCUBATOROhmeda Medical · 2001-03-21K993407OHMEDA MEDICAL OMNIBEDOhmeda Medical · 2000-01-05

Official Source

View FDA Recall →

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

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