Philips Intera 0.5T MRI System Patient Table Floor Plate Installation Defect
Philips is recalling 14 Intera 0.5T MRI systems due to potential misinstallation of the patient support table floor plate, which could affect equipment stability and patient safety.
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 recall involving a structural installation defect in patient support equipment. While no injuries have been reported, incorrect floor plate installation on an MRI table presents a risk of harm to patients during imaging procedures.
Plain-English summary
Philips North America LLC is recalling 14 units of the Intera 0.5T Standard Magnetic Resonance System due to potential misinstallation of the patient support table floor plate.
The floor plate may be incorrectly installed, which could affect equipment stability and patient safety. The affected units have serial numbers 6047, 6018, 6023, 6027, 6031, 6044, 6060, 10306, 6015, 6061, 6025, 6054, 6001, and 6066. These systems have worldwide distribution, including throughout the United States and over 100 other countries.
The recalled product
- Product
- Intera 0.5T Standard, Magnetic Resonance System.
- Manufacturer
- Philips North America Llc
- Affected units
- 14
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 (16)
- Model No. 781101
- UDI-DI n/a
- Serial No. 6047
- 6018
- 6023
- 6027
- 6031
- 6044
- 6060
- 10306
- 6015
- 6061
- 6025
- 6054
- 6001
- 6066.
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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