Date Initiated by Firm |
December 14, 2006 |
Date Posted |
January 25, 2007 |
Recall Status1 |
Terminated 3 on October 14, 2011 |
Recall Number |
Z-0370-2007 |
Recall Event ID |
37012 |
510(K)Number |
K031333
|
Product Classification |
angiographic x-ray systems - Product Code IZI
|
Product |
FD 10/10 X-Ray System, Angiograph, bi-plane digital Allura FD, 10' detector |
Code Information |
site numbers provided in the product listing for Z-0366-2007 |
Recalling Firm/ Manufacturer |
Philips Medical Systems North America Co. Phillips 22100 Bothell Everett Hwy Bothell WA 98021-8431
|
For Additional Information Contact |
Sarah Baxter 425-487-7665
|
Manufacturer Reason for Recall |
Movement of the AD5 table or Lateral C-arm (LARC). The table and/or LARC will not move upon request, will move slowly when movement is requested or will not stop moving when requested.
|
FDA Determined Cause 2 |
Other |
Action |
On 12/14/05 and 12/20/06 the firm issued a letter dated 12/12/06 to their customers. The letter explains the problem and states that the firm will be performing mandatory upgrades to correct the situation. Consignees will be contacted to arrange for service. |
Quantity in Commerce |
140 devices total |
Distribution |
Units were distributed to hospitals and medical centers nationwide. |
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 = IZI and Original Applicant = PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
|