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U.S. Department of Health and Human Services

Class 2 Device Recall Ingenia Ambition S, Ingenia Ambition X

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 Class 2 Device Recall Ingenia Ambition S, Ingenia Ambition Xsee related information
Date Initiated by FirmMarch 25, 2019
Create DateApril 27, 2019
Recall Status1 Terminated 3 on June 04, 2020
Recall NumberZ-1240-2019
Recall Event ID 82610
510(K)NumberK181479 
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
ProductIngenia Ambition S (781359), Ingenia Ambition X (781356) with Magnet Energization Device (MED), Philips MR systems are indicated for use as a diagnostic device. The purpose of the MED is to supply power to charge the magnet. MED is abbreviation for Magnet Energize Device
Code Information US Serial Number: 47004 OUS Serial Numbers: 47001, 47002, 48000  
FEI Number 3002807880
Recalling Firm/
Manufacturer		 Philips Medical Systems Nederlands
Veenpluis 4-6
Best Netherlands
Manufacturer Reason
for Recall		Magnet Energization Device (MED) can have a residual voltage on output terminal, may cause electrical shocks to personnel servicing the MED, MDD or connected cabling.
FDA Determined
Cause 2		Device Design
ActionPhilips issued an "URGENT - Medical Device Correction" letter on 3/25/2019 via certified mail to its customers. Philips Key Markets are responsible for distributing the letters outside of the U.S. Letter identifies the problem, health risk and actions to be taken. The customers were informed that no action from the customer or user of the device is required, as the Magnet Energization Device (MED) is located in a cabinet in the Technical Room, with the output terminals of the MED located behind locked protective covers. Only qualified servicing personnel have access to this. the Magnet PHILIPS Energization Device (MED) will be replaced by a new version, which does not have this problem. If you need any further information or support concerning this issue, please INFORMATION AND contact your local Philips representative or call the Quality Specialist DI BG Q&R Post Market Surveilla at 678-2960248 or email to: Etseguenet.Kinde@philips.com.
Quantity in Commerce4 units
DistributionUS Distribution to state of: FL and Internationally to: Switzerland and Germany.
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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