Philips GYROSCAN T10-NT MRI Systems Patient Support Table Floor Plate Installation Issue
Philips North America is recalling GYROSCAN T10-NT MRI systems due to potential incorrect installation of the patient support table floor plate. Affected units should be verified for proper installation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 medical device recall involving a structural installation defect on the patient support system. While no injuries have been reported, improper floor plate installation could compromise patient safety and creates a risk-of-harm situation requiring preventive action.
Plain-English summary
Philips North America is recalling 40 units of the GYROSCAN T10-NT Magnetic Resonance System due to a potential installation defect.
The issue involves the patient support table floor plate, which may have been incorrectly installed on affected units. This could compromise the structural stability of the patient support system.
Affected units are identified by specific serial numbers and are located worldwide, including throughout the United States. Healthcare facilities that operate affected systems should contact their manufacturer representative to verify correct installation of the floor plate and obtain corrective guidance if needed.
Patients and healthcare providers using the affected systems are advised to have installation verification performed before continued use.
The recalled product
- Product
- GYROSCAN T10-NT, Magnetic Resonance System.
- Manufacturer
- Philips North America Llc
- Affected units
- 40
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. 78108
- UDI-DI n/a
- Serial No. 4221
- 4332
- 4209
- 4235
- 4083
- 4368
- 4090
- 4171
- 4182
- 4217
- 4276
- 4360
- 4115
- 4157
- 4181
- 4215
- 4234
- 4238
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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