FDA Medical Device Recalls (openFDA)
Datex Ohmeda, Inc. dba GE Healthcare: Ohmeda Giraffe SPOT PT Lite Phototherapy System
- Recall number
- Z-0160-06
- Recalling firm
- Datex Ohmeda, Inc. dba GE Healthcare
- Product
- Ohmeda Giraffe SPOT PT Lite Phototherapy System
- Status
- Terminated
- Initiated
- 2005-08-05
- Posted
- 2005-11-18
- Terminated
- 2007-10-24
- Reason
- Phototherapy medical device may lose its position and can cause a safety hazard to the patient.
- 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
- 2701 devices
- Distribution
- Product was distributed to medical facilities in the US and international subsidiaries and distributors.
- Lot, serial or model codes
- Serial numbers: HEBE50008 - HEBE50019; HEBF50001 - HEBF50311; HEBG50001 - HEBG50751; HEBH50001 - HEBH50950; HEBJ50000 - HEBJ50432; HEBG54001 - HEBG54035; HEBH54001 - HEBH54999; HEBH55000 - HEBH55041; HEBJ55033 - HEBJ55036;
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LBI
- Firm FEI
- 1121732
- Firm city
- Laurel
- Firm state
- MD
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28