Philips MRI System Patient Support Table Floor Plate Installation Issue
Philips is recalling 9 Intera 3.0T Quasar Dual MRI systems (Model 781150) distributed worldwide. The patient support table floor plate may be incorrectly installed on these units.
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 an FDA Class II recall involving a risk-of-harm medical device (patient support during MRI procedures) with no reported illnesses or injuries mentioned in the source. The installation issue poses a potential patient safety risk, meeting the criteria for Score 3 per the rubric.
Plain-English summary
Philips North America LLC is recalling 9 units of the Intera 3.0T Quasar Dual Magnetic Resonance System (Model No. 781150). The affected units are identified by serial numbers: 5729, 10138, 10123, 10746, 10136, 10103, 5714, 10182, and 5704.
The patient support table floor plate on these units may be incorrectly installed. The U.S. Food and Drug Administration has classified this as a Class II recall.
These MRI systems have been distributed worldwide, including throughout the United States and internationally.
The recalled product
- Product
- Intera 3.0T Quasar Dual, Magnetic Resonance System.
- Manufacturer
- Philips North America Llc
- Hazard
- improper-installation
- fall-risk
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 (11)
- Model No. 781150
- UDI-DI n/a
- Serial No. 5729
- 10138
- 10123
- 10746
- 10136
- 10103
- 5714
- 10182
- 5704.
Distribution
Distributed nationwide across the United States.
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