Z-0160-06

Ohmeda Giraffe SPOT PT Lite Phototherapy System

Name: Z-0160-06 Ohmeda Giraffe SPOT PT Lite Phototherapy System
Creator: Datex Ohmeda, Inc. dba GE Healthcare
Published: 2005-08-05
License: https://open.fda.gov/license/

GE Healthcare / initiated 2005-08-05 / Terminated

FDA source

Datex Ohmeda, Inc. dba GE Healthcare began a recall of Ohmeda Giraffe SPOT PT Lite Phototherapy System on 2005-08-05. The reason FDA records is "Phototherapy medical device may lose its position and can cause a safety hazard to the patient". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0160-06
Status: Terminated
Initiated: 2005-08-05
Posted: 2005-11-18
Terminated: 2007-10-24
Recalling firm: GE Healthcare
Product: Ohmeda Giraffe SPOT PT Lite Phototherapy System
Product code: LBI Unit, Neonatal Phototherapy
Reason for recall: Phototherapy medical device may lose its position and can cause a safety hazard to the patient.
FDA root cause: Other
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.
Quantity in commerce: 2701 devices
Distribution: Product was distributed to medical facilities in the US and international subsidiaries and distributors.
Product codes and lots: Serial numbers: HEBE50008 - HEBE50019; HEBF50001 - HEBF50311; HEBG50001 - HEBG50751; HEBH50001 - HEBH50950; HEBJ50000 - HEBJ50432; HEBG54001 - HEBG54035; HEBH54001 - HEBH54999; HEBH55000 - HEBH55041; HEBJ55033 - HEBJ55036;

Product code LBI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)