Date Initiated by Firm |
August 10, 2003 |
Date Posted |
September 11, 2003 |
Recall Status1 |
Terminated 3 on January 13, 2005 |
Recall Number |
Z-1214-03 |
Recall Event ID |
27013 |
510(K)Number |
K912470
|
Product Classification |
Table, Radiographic, Non-Tilting, Powered - Product Code IZZ
|
Product |
Diagnost 94 |
Code Information |
See Diagnost 96 above |
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 |
Potential for table to move by itself
|
FDA Determined Cause 2 |
Other |
Action |
The firm issued a letter dated 8/10/03 informing the consignees of the error and advising that a service employee will be visiting each site for software upgrade. |
Quantity in Commerce |
see Diagnost 96 above |
Distribution |
The firm distributed devices to hospitals and medical centers located throughout the U.S. |
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.
|
510(K) Database |
510(K)s with Product Code = IZZ and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.
|