Date Initiated by Firm |
November 20, 2003 |
Date Posted |
December 24, 2003 |
Recall Status1 |
Terminated 3 on January 13, 2005 |
Recall Number |
Z-0271-04 |
Recall Event ID |
27839 |
Product Classification |
System, X-Ray, Stationary - Product Code KPR
|
Product |
Philips Digital Diagnost VT |
Code Information |
See list above. Site numbers could not be separated by model. |
Recalling Firm/ Manufacturer |
Philips Medical Systems Sales & Service Region No. America 22100 Bothell Everett Highway Bothell WA 98041
|
For Additional Information Contact |
425-487-7000
|
Manufacturer Reason for Recall |
The support chain attachment on the detector carriage may fail and cause the counter weights or detector to fall.
|
FDA Determined Cause 2 |
Other |
Action |
The firm mailed a recall letter to affected customers on November 20, 2003 notifying them of the problem. The letter states upgrades will be completed by the end of April 2004. |
Quantity in Commerce |
70 devices total |
Distribution |
The firm distributed to medical facilities nationwide. |
Total Product Life Cycle |
TPLC Device Report
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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.
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