Magnetic Resonance System Patient Support Table Floor Plate Installation Issue
Philips is recalling the MR 7700 Magnetic Resonance System due to potential incorrect installation of the patient support table floor plate. The recall affects 26 units distributed worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is classified as FDA Class II with no reported illnesses or injuries. The incorrect installation of a patient support table floor plate constitutes a risk-of-harm product where injury has not yet been reported, meeting the criteria for a High severity rating.
Plain-English summary
Philips North America LLC is recalling the MR 7700 Magnetic Resonance System. The recall affects 26 units distributed worldwide, including throughout the United States and multiple other countries.
The patient support table floor plate on affected units may have been incorrectly installed. The patient support table is the component used to position patients during magnetic resonance imaging procedures.
For detailed information about this recall and any associated guidance, refer to FDA recall number Z-1588-2024.
The recalled product
- Product
- MR 7700, Magnetic Resonance System.
- Manufacturer
- Philips North America Llc
- Hazard
- Affected units
- 26
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model No. 782120
- UDI-DI 884838104112
- Serial No. 65051
- 65005
- 65000
- 65002
- 65003
- 65001
- 65004
- 65009
- 65012
- 65013
- 65015
- 65017
- 65020
- 65019
- 65021
- 65023
- 65024
- 65025
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 41 recalled by Philips North America Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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