Date Initiated by Firm |
August 05, 2005 |
Date Posted |
November 18, 2005 |
Recall Status1 |
Terminated 3 on October 24, 2007 |
Recall Number |
Z-0160-06 |
Recall Event ID |
32920 |
Product Classification |
Unit, Neonatal Phototherapy - Product Code LBI
|
Product |
Ohmeda Giraffe¿ SPOT PT Lite¿ Phototherapy System |
Code Information |
Serial numbers: HEBE50008 - HEBE50019; HEBF50001 - HEBF50311; HEBG50001 - HEBG50751; HEBH50001 - HEBH50950; HEBJ50000 - HEBJ50432; HEBG54001 - HEBG54035; HEBH54001 - HEBH54999; HEBH55000 - HEBH55041; HEBJ55033 - HEBJ55036; |
Recalling Firm/ Manufacturer |
Datex Ohmeda, Inc. dba GE Healthcare 8880 Gorman Rd Laurel MD 20723-5800
|
For Additional Information Contact |
Ann Lebar 414-362-2703
|
Manufacturer Reason for Recall |
Phototherapy medical device may lose its position and can cause a safety hazard to the patient.
|
FDA Determined Cause 2 |
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 in Commerce |
2701 devices |
Distribution |
Product was distributed to medical facilities in the US and international subsidiaries and distributors. |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|