Recall Z-0160-06 ยท LBI Unit, Neonatal Phototherapy
Datex Ohmeda, Inc. dba GE Healthcare
Ohmeda Giraffe SPOT PT Lite Phototherapy System
| Date | Nov 18, 2005 (initiated Aug 5, 2005) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.