Philips MRI System Patient Support Table Floor Plate Installation Defect
Philips is recalling 12 Intera 1.5T MRI systems worldwide because the patient support table floor plate may be incorrectly installed. Healthcare facilities should verify proper installation.
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 an FDA Class II recall with no reported injuries or deaths. The hazard involves a potential installation defect—the floor plate may be incorrectly installed—which represents a risk-of-harm scenario but without documented patient injury. Per the severity rubric, this qualifies as High (score 3) as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Philips North America is recalling 12 Intera 1.5T Explorer/Nova Dual Magnetic Resonance Systems distributed worldwide. The recall addresses a potential installation defect involving the patient support table floor plate.
The patient support table floor plate may be incorrectly installed on affected units. An improper installation of this structural component could compromise system safety during patient procedures.
The affected systems carry the following serial numbers: 8918, 10035, 8803, 10037, 9025, 10022, 10638, 10640, 8743, 8651, 10091, and 8690. Owners and users of these MRI systems should contact Philips North America to verify correct installation of the patient support table floor plate.
The recalled product
- Product
- Intera 1.5T Explorer/Nova Dual, Magnetic Resonance System.
- Manufacturer
- Philips North America Llc
- Hazard
- Affected units
- 12
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 (14)
- Model No. 781108
- UDI-DI n/a
- Serial No. 8918
- 10035
- 8803
- 10037
- 9025
- 10022
- 10638
- 10640
- 8743
- 8651
- 10091
- 8690.
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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