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Terminated

Ohmeda Giraffe SPOT PT Lite Phototherapy System

FDA Recall Z-0160-06 · Posted 2005-11-18

Recalling FirmDatex Ohmeda, Inc. dba GE Healthcare
Recall StatusTerminated
Product CodeLBI
Date Initiated2005-08-05
Date Terminated2007-10-24
Product Quantity2701 devices

Reason for Recall

Phototherapy medical device may lose its position and can cause a safety hazard to the patient.

Firm Action

The firm notified consignees by letter on 08/05/2005 and advised of field correction of the devices in 2 phases. The letter is lot specific and provides for an interim workaround and includes an adhesive sticker and instructions for tagging the device with a warning statement containing restriction for use : 'This phototherapy light should ONLY be used on patients in closed incubators.' The letter further advises of firm''s plan to provide free, mandatory repair at a later date, pending hardware solution.

Root Cause

Other

Distribution Pattern

Product was distributed to medical facilities in the US and international subsidiaries and distributors.

Official Source

View FDA Recall →

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

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