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U.S. Department of Health and Human Services

Class 2 Device Recall Intera 1.0T Power/Pulsar

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 Class 2 Device Recall Intera 1.0T Power/Pulsarsee related information
Date Initiated by FirmDecember 21, 2018
Date PostedFebruary 22, 2019
Recall Status1 Terminated 3 on November 19, 2020
Recall NumberZ-0876-2019
Recall Event ID 82038
510(K)NumberK052078 
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
ProductIntera 1.0T Power/Pulsar, Model Number 781103. 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
ActionUrgent Medical Device Correction notification letters dated December 2018 were sent to customers.
Quantity in Commerce11226 total
DistributionU.S. Nationwide distribution.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LNH
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