—#202289

Product

MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7700)

FDA product code: LNH — System, Nuclear Magnetic Resonance Imaging
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K213583
Affected lot / code info: Product Number: 782120: UDI-DI: 00884838104112; Serial Numbers: 65041 65031 65030 65025 65023 65019 65013 65009 6500865007 65006 65005 65004 65003 65002 65000 65020; Product Number 782130: UDI-DI: 00884838104402; Serial Numbers: 4530145298 45007 45297

Why it was recalled

During installation of the SmokeDetector Interlock, a connecting cable, between the SmokeDetector Interlock and the host PC, may not have been properly installed. This connection is used for service diagnostics and does not impact the functionality of the system and/or the SmokeDetector Interlock system.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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. Ifa 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 the s

Recalling firm

Firm: Philips North America
Address: 222 Jacobs St, Cambridge, Massachusetts 02141-2296

Distribution

Distribution pattern: US Nationwide. Global Distribution.

Timeline

Recall initiated: 2023-06-12
Posted by FDA: 2023-08-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #202289. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.