Ingenia Elition S Magnetic Resonance (MR) system, Product Numbers 781357 and 782106

FDA device recall Z-2396-2023 · posted 2023-08-11 · Open, Classified

Recall details

Recalling firm

Philips North America

Reason for recall

The system operator is able to bypass the SmokeDetector Interlock system locking mechanism after a smoke detection by power cycling the system.

Action taken

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

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

LNH

Quantity affected

640 total

Distribution

US Nationwide. Global Distribution.

Date initiated

2023-06-12

Date posted

2023-08-11

Location

Cambridge, MA

Related 510(k) clearances