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MR 7700 Magnetic Resonance (MR) system, Product Numbers… recallZ-2397-2023 · Philips North America · initiated Jun 12, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Philips North America or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Under Investigation by firm

What the company is doing

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

Recall details

Recall number
Z-2397-2023
Status
Open, Classified
Initiated by the company
Jun 12, 2023
Posted by the FDA
Aug 11, 2023
Recalling firm
Philips North America
Quantity
640 total
Product code
LNH
FDA submissions
K213583
Distribution
US Nationwide. Global Distribution.

Product description

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

Code information (models, lots, serial numbers)

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 65012 65034 65001; Product Number 782130: UDI-DI: 00884838104402; Serial Numbers: 45301 45298 45007 45297 45557

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 92720).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page