MRI System Patient Support Table Floor Plate May Be Incorrectly Installed
Philips North America is recalling 7 GYROSCAN T5 MRI systems worldwide due to potential incorrect installation of the patient support table floor plate, which may create a safety risk during patient table 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: FDA Class II device recall with a structural installation defect affecting patient safety on a critical medical system. However, no illnesses or injuries have been reported, and the hazard remains theoretical at this stage, placing this at the High severity level per the rubric.
Plain-English summary
Philips North America LLC is recalling 7 GYROSCAN T5 Magnetic Resonance (MRI) Systems worldwide due to a potential installation defect affecting the patient support table floor plate.
The patient support table floor plate may be incorrectly installed. This defect could pose a safety risk during normal use of the patient support table. No illnesses or injuries have been reported at this time.
Affected units carry Model No. 78104 and the following Serial Numbers: 605, 889, 915, 938, 663, 600, and 891. These systems have been distributed to healthcare facilities worldwide across numerous countries including the United States, Canada, Europe, Asia, and other regions.
Healthcare facilities should verify the proper installation of the patient support table floor plate on affected systems. Facilities should contact Philips North America LLC for technical assistance and corrective action guidance.
The recalled product
- Product
- GYROSCAN T5, Magnetic Resonance System.
- Manufacturer
- Philips North America Llc
- Hazard
- installation-defect
- structural-defect
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 (9)
- Model No. 78104
- UDI-DI n/a
- Serial No. 605
- 889
- 915
- 938
- 663
- 600
- 891.
Distribution
Distributed nationwide across the United States.
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