MRI System Patient Support Table Floor Plate Installation Defect
Philips Intera 1.0T MRI systems may have an incorrectly installed patient support table floor plate. This defect could affect patient safety during magnetic resonance imaging procedures.
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 with no reported injuries or illnesses. The hazard is a potential installation defect affecting patient safety equipment, but remains theoretical. Per the rubric, a risk-of-harm product with no reported incidents scores at most 3 (High).
Plain-English summary
Philips North America has recalled the Intera 1.0T Omni/Stellar Magnetic Resonance System due to a potential installation defect. The patient support table floor plate may be incorrectly installed on affected units.
This recall involves 27 units that have been distributed worldwide, including throughout the United States. The defect affects equipment used for medical imaging procedures.
An incorrectly installed floor plate could compromise proper patient positioning and support during magnetic resonance imaging. Healthcare facilities operating these systems should verify the correct installation of the patient support table floor plate and contact Philips North America for guidance if the defect is found.
The recalled product
- Product
- Intera 1.0T Omni/Stellar, Magnetic Resonance System.
- Manufacturer
- Philips North America Llc
- Affected units
- 27
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. 781102
- UDI-DI n/a
- Serial No. 7069
- 7213
- 7238
- 10045
- 7248
- 10341
- 10073
- 7020
- 7247
- 7081
- 7141
- 7120
- 7116
- 10334
- 10047
- 7226
- 7111
- 7203
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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