Ohmeda Giraffe SPOT PT Lite Phototherapy System
FDA device recall Z-0160-06 · posted 2005-11-18 · Terminated
Recall details
- Recalling firm
- Datex Ohmeda, Inc. dba GE Healthcare
- Reason for recall
- Phototherapy medical device may lose its position and can cause a safety hazard to the patient.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LBI
- Quantity affected
- 2701 devices
- Distribution
- Product was distributed to medical facilities in the US and international subsidiaries and distributors.
- Date initiated
- 2005-08-05
- Date posted
- 2005-11-18
- Date terminated
- 2007-10-24
- Location
- Laurel, MD
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