Philips Intera 1.5T MRI System Patient Support Table Floor Plate Installation Defect
Philips is recalling Intera 1.5T magnetic resonance systems worldwide because the patient support table floor plate may be incorrectly installed, potentially affecting table 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 with no reported injuries or illnesses. The hazard—incorrect installation of patient support equipment—poses a direct risk of harm to patients but is preventable through corrective action. This fits the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Philips North America LLC is recalling the Intera 1.5T Power/Pulsar Magnetic Resonance System. The recall affects 115 units distributed worldwide, including the United States and numerous international locations. The issue involves the patient support table floor plate, which may be incorrectly installed.
An incorrectly installed floor plate on the patient support table may affect the proper functioning and stability of the table during patient procedures. This could pose a risk to patient safety.
The recall applies to units with model number 781105 and specific serial numbers identified by Philips. Healthcare facilities using affected MRI systems should contact Philips North America LLC immediately for guidance on inspection and corrective action.
The recalled product
- Product
- Intera 1.5T Power/Pulsar, Magnetic Resonance System.
- Manufacturer
- Philips North America Llc
- Affected units
- 115
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. 781105
- UDI-DI n/a
- Serial No. 8342
- 8104
- 8899
- 8557
- 8797
- 8665
- 8154
- 8590
- 8333
- 8418
- 8615
- 8963
- 8846
- 8216
- 8112
- 8296
- 8384
- 8626
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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