MRI System Patient Support Table Floor Plate May Be Incorrectly Installed
Philips Intera CV MRI systems may have an incorrectly installed patient support table floor plate. Eight units have been recalled due to this installation defect.
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 medical device recall involving a structural installation defect in a patient-facing component. Although no injuries have been reported, an incorrectly installed floor plate on a patient support table represents a direct risk of harm to patients, meeting the criteria for High severity.
Plain-English summary
Philips North America LLC is recalling 8 units of the Intera CV Magnetic Resonance System. The patient support table floor plate may be incorrectly installed on these systems.
The patient support table is the component that supports patients during MRI imaging procedures. The recalled units are identified by serial numbers 8528, 8653, 8907, 8869, 8703, 9017, 8756, and 8014.
These systems were distributed worldwide, including throughout the United States and internationally.
The recalled product
- Product
- Intera CV, Magnetic Resonance System.
- Manufacturer
- Philips North America Llc
- Hazard
- installation-defect
- 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 (10)
- Model No. 781107
- UDI-DI n/a
- Serial No. 8528
- 8653
- 8907
- 8869
- 8703
- 9017
- 8756
- 8014.
Distribution
Distributed nationwide across the United States.
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