Date Initiated by Firm |
December 21, 2018 |
Date Posted |
February 22, 2019 |
Recall Status1 |
Terminated 3 on November 19, 2020 |
Recall Number |
Z-0916-2019 |
Recall Event ID |
82038 |
510(K)Number |
K153324
|
Product Classification |
System, nuclear magnetic resonance imaging - Product Code LNH
|
Product |
Ingenia 1.5T S, Model Number 781347. Nuclear Magnetic Resonance Imaging System |
Code Information |
All systems |
Recalling Firm/ Manufacturer |
Philips Medical Systems Nederlands Veenpluis 4-6 Best Netherlands
|
Manufacturer Reason for Recall |
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
|
FDA Determined Cause 2 |
Unknown/Undetermined by firm |
Action |
Urgent Medical Device Correction notification letters dated December 2018 were sent to customers. |
Quantity in Commerce |
11226 total |
Distribution |
U.S. Nationwide distribution. |
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 = LNH and Original Applicant = PHILIPS MEDICAL SYSTEMS, NEDERLANDS B.V.
|