Datex Ohmeda, Inc. dba GE Healthcare Ohmeda Giraffe SPOT PT Lite Phototherapy System Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Ohmeda Giraffe SPOT PT Lite Phototherapy System
Brand
Datex Ohmeda, Inc. dba GE Healthcare
Lot Codes / Batch Numbers
Serial numbers: HEBE50008 - HEBE50019, HEBF50001 - HEBF50311, HEBG50001 - HEBG50751, HEBH50001 - HEBH50950, HEBJ50000 - HEBJ50432, HEBG54001 - HEBG54035, HEBH54001 - HEBH54999, HEBH55000 - HEBH55041, HEBJ55033 - HEBJ55036
Products Sold
Serial numbers: HEBE50008 - HEBE50019; HEBF50001 - HEBF50311; HEBG50001 - HEBG50751; HEBH50001 - HEBH50950; HEBJ50000 - HEBJ50432; HEBG54001 - HEBG54035; HEBH54001 - HEBH54999; HEBH55000 - HEBH55041; HEBJ55033 - HEBJ55036;
Datex Ohmeda, Inc. dba GE Healthcare is recalling Ohmeda Giraffe SPOT PT Lite Phototherapy System due to Phototherapy medical device may lose its position and can cause a safety hazard to the patient.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Phototherapy medical device may lose its position and can cause a safety hazard to the patient.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IN
Page updated: Jan 10, 2026