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Terminated

Servo Controlled Oxygen System for Ohmeda''s Medical Giraffe OmniBed and Ohmeda''s Medical Girraffe Incubators

FDA Recall Z-1064-03 · Posted 2003-07-29

Recalling FirmOhmeda Medical, A division of Datex-Ohmeda, Inc.
Recall StatusTerminated
Product Code80FMZ
Date Initiated2003-06-13
Date Terminated2003-07-29
Product Quantity157 units

Reason for Recall

Firm's received complaints of medical device malfunction affecting instrument's calibration and alarm systems.

Firm Action

Recalling firm notified foreign distributors and domestic consignees by e-mail and phone on 6/13/2003. Foreign regional distributors were requested to manage the recall. The notification described various instrument problems and remedial action available via the firm''s field action retrofit kits, #6600-0126-850 for the Giraffe OmniBed and #6600-0261-850 for the Giraffe Incubator.

Root Cause

Other

Distribution Pattern

Devices were sold to 15 international distributors and one domestic end user.

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 · 2002-05-09

Official Source

View FDA Recall →

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

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