Philips MR 5300 MRI System Patient Support Table Floor Plate May Be Incorrectly Installed
Philips is recalling 166 units of the MR 5300 Magnetic Resonance System worldwide because the patient support table floor plate may be incorrectly installed on affected units.
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: FDA Class II medical device recall for a structural installation defect affecting patient-use equipment. No injuries or hospitalizations have been reported. The defect poses a potential risk of harm due to equipment instability, falling under the criterion for High severity: a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Philips North America LLC is recalling 166 units of the MR 5300 Magnetic Resonance System due to a potential installation defect. The systems have been distributed worldwide to medical imaging facilities.
The patient support table floor plate may be incorrectly installed on the recalled units. An incorrectly installed floor plate could affect the stability and integrity of the patient support table during use.
Healthcare facilities and imaging centers operating the MR 5300 system should verify the proper installation of the patient support table floor plate on their equipment. Customers should contact Philips North America LLC for specific instructions regarding their units and for information on how to confirm whether their system is affected by this recall.
The recalled product
- Product
- MR 5300, Magnetic Resonance System.
- Manufacturer
- Philips North America Llc
- Affected units
- 166
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. 782110
- UDI-DI 884838099364
- Serial No. 63029
- 63087
- 63014
- 63103
- 63000
- 63006
- 63007
- 63001
- 63008
- 63010
- 63013
- 63015
- 63021
- 63022
- 63039
- 63023
- 63024
- 63026
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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