MRI patient support table floor plate may be incorrectly installed
Philips Intera 1.0T MRI systems may have patient support table floor plates that are incorrectly installed. The defect poses a potential safety risk to patients. Facilities should verify installation and contact Philips service personnel for inspection.
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: The recall involves a structural defect in patient support equipment that could cause falls or injury, meeting the criterion for risk-of-harm products. No injuries, hospitalizations, or adverse events have been reported, and the defect is correctible through service inspection.
Plain-English summary
Philips North America LLC is recalling 19 Intera 1.0T Power/Pulsar Magnetic Resonance (MRI) systems due to a potential installation defect affecting the patient support table floor plate.
The floor plate may be incorrectly installed, which could pose a safety risk during patient procedures or facility use. The 19 affected units are distributed worldwide, including throughout the United States.
No injuries or adverse events have been reported. Facilities with affected systems should contact Philips North America LLC service personnel to inspect the floor plate installation and make corrections if necessary.
The recalled product
- Product
- Intera 1.0T Power/Pulsar, Magnetic Resonance System.
- Manufacturer
- Philips North America Llc
- Affected units
- 19
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. 781103
- UDI-DI n/a
- Serial No. 7062
- 7164
- 7102
- 7113
- 7084
- 10381
- 7097
- 10383
- 10384
- 10391
- 7150
- 7074
- 7237
- 7190
- 7198
- 10413
- 10382
- 7103
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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