Date Initiated by Firm |
December 01, 2016 |
Date Posted |
January 20, 2017 |
Recall Status1 |
Terminated 3 on August 10, 2017 |
Recall Number |
Z-0925-2017 |
Recall Event ID |
75845 |
510(K)Number |
K133292
|
Product Classification |
Interventional Fluoroscopic X-Ray System - Product Code OWB
|
Product |
Allura Xper FD20/15 R8.2 722058 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electro Physiology(EP).
|
Code Information |
159, 183 |
Recalling Firm/ Manufacturer |
Philips Electronics North America Corporation 3000 Minuteman Rd Andover MA 01810-1032
|
For Additional Information Contact |
800-722-9377
|
Manufacturer Reason for Recall |
Due to a production error, screws were not tightened to specified torque. These screws may come loose from the C-arm shaft causing the C-arm to rotate uncontrolled.
|
FDA Determined Cause 2 |
Process control |
Action |
Customers were notified of the recall via letter sent on 12/1/16. The letter explains the issue and the action that Philips plans to take. |
Quantity in Commerce |
2 |
Distribution |
US: WA
OUS: China, Spain, Korea, Republic of, Germany |
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 = OWB and Original Applicant = PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
|