Ohmeda Giraffe SPOT PT Lite Phototherapy System

Date posted by the FDA

Nov. 18, 2005

Status

Terminated

Filed by

Datex Ohmeda, Inc. dba GE Healthcare

Product

Ohmeda Giraffe SPOT PT Lite Phototherapy System

Reason

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

Distribution pattern

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

Quantity

2701 devices

Codes and lots

Serial numbers: HEBE50008 - HEBE50019; HEBF50001 - HEBF50311; HEBG50001 - HEBG50751; HEBH50001 - HEBH50950; HEBJ50000 - HEBJ50432; HEBG54001 - HEBG54035; HEBH54001 - HEBH54999; HEBH55000 - HEBH55041; HEBJ55033 - HEBJ55036;

Recall started

Aug. 5, 2005

Device type

Unit, Neonatal Phototherapy

Root cause (FDA)

Other

What the company told customers

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.

Recall number

Z-0160-06

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-0160-06. The agency record governs; check it and the company before acting.