Philips Intera 1.5T MRI System Patient Support Table Installation Defect
Philips is recalling certain Intera 1.5T MRI systems because the patient support table floor plate may be incorrectly installed, which could affect 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: This Class II recall concerns a potential installation defect on a medical imaging system that could pose a patient safety risk, but no injuries have been reported. It meets the rubric criterion for High severity as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Philips North America LLC is recalling Intera 1.5T Omni/Stellar Magnetic Resonance (MRI) systems because the patient support table floor plate may be incorrectly installed on some affected units.
The affected units are Model No. 781104 with the following serial numbers: 8483, 8526, 8257, 8171, 8731, 8126, 10403, 10401, 10410, 10407, 8266, 8286, 8246, 8725, 8556, 8338, 8625, 8516, 8332, 8138, 8921, 8359. In total, 22 units have been identified, distributed across the United States and numerous countries worldwide.
Healthcare facilities with these systems should verify that the patient support table floor plate is properly installed and contact Philips North America LLC for guidance if installation issues are suspected.
The recalled product
- Product
- Intera 1.5T Omni/Stellar, Magnetic Resonance System.
- Manufacturer
- Philips North America Llc
- Affected units
- 22
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. 781104
- UDI-DI n/a
- Serial No. 8483
- 8526
- 8257
- 8171
- 8731
- 8126
- 10403
- 10401
- 10410
- 10407
- 8266
- 8286
- 8246
- 8725
- 8556
- 8338
- 8625
- 8516
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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