Ohmeda Giraffe SPOT PT Lite Phototherapy System
Hazard
Phototherapy medical device may lose its position and can cause a safety hazard to the patient.
What You Should Do
Remedy
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.
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Products
Ohmeda Giraffe SPOT PT Lite Phototherapy System
- Brand
- Datex Ohmeda, Inc. dba GE Healthcare
- UPC
- Serial numbers: HEBE50008 - HEBE50019; HEBF50001 - HEBF50311; HEBG50001 - HEBG50751; HEBH50001 - HEBH50950; HEBJ50000 - HEBJ50432; HEBG54001 - HEBG54035; HEBH54001 - HEBH54999; HEBH55000 - HEBH55041; HEBJ55033 - HEBJ55036;
Units Affected
2701 devices