|
Class 2 Device Recall MD3 |
|
Date Initiated by Firm |
April 06, 2006 |
Date Posted |
May 06, 2006 |
Recall Status1 |
Terminated 3 on May 21, 2008 |
Recall Number |
Z-0851-06 |
Recall Event ID |
35177 |
510(K)Number |
K904012
|
Product Classification |
X Ray System - Product Code JAA
|
Product |
MD3 X-ray system |
Code Information |
Site numbers 59515, 38929, 76329, 83654, 82673, 35471, 59524, 86146, 38922, 101151, 38714, 38716, 44865, 6847, 103855, 26071, 103856, 40941, 83047, 62502, 38266, 38422, X1198, 50317, 38289, 17669, 6931, X0917, 26019, 26020, 13661, 38418, 59571, 41462, 82721, 101782, 103209 |
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 |
Potential for unexpected table movement.
|
FDA Determined Cause 2 |
Other |
Action |
On 4/6/06 the firm issued a letter to consignees advising of the problem. The letter advises consignees to conduct a test on their unit(s) for a possible short until the firm is able to upgrade the units.
|
Quantity in Commerce |
37units |
Distribution |
Units were distributed to hospitals and medical centers located throughou the US. |
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 = JAA and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.
|
|
|
|