Date Initiated by Firm |
December 08, 2020 |
Date Posted |
January 28, 2021 |
Recall Status1 |
Completed |
Recall Number |
Z-0727-2021 |
Recall Event ID |
87039 |
510(K)Number |
K173433
|
Product Classification |
Interventional fluoroscopic x-ray system - Product Code OWB
|
Product |
ProxiDiagnost N90 Image-intensified fluoroscopic x-ray system |
Code Information |
Pending |
Recalling Firm/ Manufacturer |
PHILIPS HOME HEALTHCARE SOLUTION 222 Jacobs St Cambridge MA 02141-2289
|
Manufacturer Reason for Recall |
After the user selects the Lock-in command, the kV and mA values are not locked immediately and can adjust if the collimator shutter position is changed directly after the Lock-in command.
|
FDA Determined Cause 2 |
Radiation Control for Health and Safety Act |
Quantity in Commerce |
91 |
Distribution |
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.
|
510(K) Database |
510(K)s with Product Code = OWB and Original Applicant = Philips Medical Systems DMC GmbH
|