Philips MRI patient support table floor plate installation defect recall
Philips is recalling 107 Intera 1.5T MRI systems worldwide due to potential incorrect installation of the patient support table floor plate, which may create safety risks during patient use.
What this means for you
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 a Class II medical device recall involving a structural installation defect on a patient-support component. The defect presents a risk of patient harm (potential falls or injuries), but no illnesses or injuries have been reported, matching the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Philips North America LLC is recalling 107 Intera 1.5T Master/Nova Magnetic Resonance Systems (MRI systems) due to the patient support table floor plate potentially being incorrectly installed.
The incorrect installation of the floor plate could compromise the structural integrity and stability of the patient support table during clinical use. This may create a hazard when positioning patients for scanning procedures.
The affected systems have specific serial numbers and were distributed worldwide. Healthcare facilities operating affected units should contact Philips for inspection, correction procedures, and guidance on safe continued operation until repairs are completed.
The recalled product
- Product
- Intera 1.5T Master/Nova, Magnetic Resonance System.
- Manufacturer
- Philips North America Llc
- Affected units
- 107
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. 781106
- UDI-DI n/a
- Serial No. 8648
- 8650
- 8400
- 8668
- 8849
- 8788
- 8754
- 8603
- 8733
- 8488
- 8928
- 8866
- 8224
- 8368
- 8254
- 10131
- 8379
- 8827
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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