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U.S. Department of Health and Human Services

Class 2 Device Recall Ingenia Elition S

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  Class 2 Device Recall Ingenia Elition S see related information
Date Initiated by Firm June 12, 2023
Date Posted August 11, 2023
Recall Status1 Open3, Classified
Recall Number Z-2397-2023
Recall Event ID 92720
510(K)Number K213583  
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
Product MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7700)
Code Information Product Number: 782120: UDI-DI: 00884838104112; Serial Numbers: 65041 65031 65030 65025 65023 65019 65013 65009 65008 65007 65006 65005 65004 65003 65002 65000 65020; Product Number 782130: UDI-DI: 00884838104402; Serial Numbers: 45301 45298 45007 45297
Recalling Firm/
Philips North America
222 Jacobs St
Cambridge MA 02141-2296
Manufacturer Reason
for Recall
The system operator is able to bypass the SmokeDetector Interlock system locking mechanism after a smoke detection by powercycling the system.
FDA Determined
Cause 2
Under Investigation by firm
Action An URGENT Medical Device Correction Notice dated 6/5/23 was sent to customers. Actions that should be taken by the customer / user in order to prevent risks for patients or users: 4.1. Philips has installed a SmokeDetector Interlock feature on all the systems listed in Appendix A. ¿ Post this notice near the affected MR system(s) for ease of reference. ¿ Circulate this notice to all users of this device so that they are aware of the product issue and associated hazard/harm until this issue has been resolved. ¿ Please complete and return the attached updated customer response form to Philips promptly and no later than 30 days from receipt of this letter. Philips is requesting that even if you acknowledged a previous version of this letter that you also respond with an acknowledgment to this updated letter. 4.2. The SmokeDetector Interlock feature is integrated with the MR System and powers off the relevant part of the system (Gradient Amplifier) when smoke is detected in order to prevent further development of smoke and/or fire. If the SmokeDetector Interlock has detected smoke and has powered off the Gradient Amplifier: ¿ Remove patient from the system according to the instructions for use because power to the tabletop will still be active ¿ Scanning is disabled until Philips service has checked the system. Do not attempt to continue scanning. ¿ Immediately inform Philips Service ¿ DO NOT attempt to restart or perform a power cycle of the system 4.3. If a user experiences smoke, fire, or severe image quality issues (image artifacts caused by electrical disturbances): ¿ Immediately stop scanning and evacuate the patient from the Examination Room. ¿ Check Examination Room for a developing fire. ¿ If a developing fire is sensed, adhere to established fire emergency procedures, which may include switching off power to the complete system and/or removing the magnet field by using the Emergency Magnet Off button ¿ Scanning is disabled until Philips service has checked t
Quantity in Commerce 601 total
Distribution US Nationwide. Global 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = LNH and Original Applicant = Philips Medical Systems Nederland B.V.