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U.S. Department of Health and Human Services

Class 2 Device Recall Multiva 1.5T 8 R5 (ZBO)

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  Class 2 Device Recall Multiva 1.5T 8 R5 (ZBO) see related information
Date Initiated by Firm December 21, 2018
Date Posted February 22, 2019
Recall Status1 Terminated 3 on November 19, 2020
Recall Number Z-0871-2019
Recall Event ID 82038
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
Product Multiva 1.5T 8 R5 (ZBO), Model Number 781072. 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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