Date Initiated by Firm | December 21, 2018 |
Date Posted | February 22, 2019 |
Recall Status1 |
Terminated 3 on November 19, 2020 |
Recall Number | Z-0875-2019 |
Recall Event ID |
82038 |
510(K)Number | K052078 |
Product Classification |
System, nuclear magnetic resonance imaging - Product Code LNH
|
Product | Intera 1.0T Omni/Stellar, Model Number 781102. 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.
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510(K) Database | 510(K)s with Product Code = LNH
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