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Terminated

Radiant Heater Door Vent for Ohmeda Medical''s Giraffe (tm) OmniBed neonate bed.

FDA Recall Z-0288-04 · Posted 2004-07-20

Recalling FirmOhmeda Medical, A Div of Datex-Ohmeda , Inc
Recall StatusTerminated
Product CodeFMZ
Date Initiated2003-10-17
Date Terminated2005-10-11
Product Quantity1404 beds

Reason for Recall

Heater vent door on neonatal incubator may malfunction.

Firm Action

The recalling firm notified domestic consignees by certified letter and international distributors by e-mail dated 10/17/2003. The recall notice was incorporated into a firm''s follow-up letter concerning an on-going product correction of the elevating base on the same neonatal beds. The letter advises of the malfunctioning heater door vent and states that the firm will replace all existing vent doors with doors made of higher temperature rated material. Firm will provide retrofit kits for consignee or service representative installation.

Root Cause

Other

Distribution Pattern

Products were sold to 365 direct accounts around the US and 58 international distributors.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K020543OHMEDA MEDICAL GIRAFFE OMNIBEDOhmeda 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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