MRI System Patient Support Table Floor Plate May Be Incorrectly Installed
Philips has recalled 50 units of its GYROSCAN ACS-NT MRI systems. The patient support table floor plate may be incorrectly installed, potentially posing a safety risk.
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 with no reported injuries or adverse events. The installation defect poses a potential risk to patient safety during MRI procedures. Per the severity rubric, risk-of-harm products without reported injury score as High (3).
Plain-English summary
The recall involves 50 units of the GYROSCAN ACS-NT Magnetic Resonance System (MRI) manufactured by Philips North America LLC. The FDA has identified that the patient support table floor plate may be incorrectly installed on these units.
Facilities with affected systems should verify the correct installation of the patient support table floor plate and contact Philips North America LLC for further guidance. The affected units have been distributed worldwide, including across the United States and to numerous international locations.
The recalled product
- Product
- GYROSCAN ACS-NT, Magnetic Resonance System.
- Manufacturer
- Philips North America Llc
- Affected units
- 50
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. 78107
- UDI-DI n/a
- Serial No. 5533
- 5414
- 5245
- 5542
- 5300
- 5227
- 5472
- 5193
- 5413
- 5216
- 5029
- 5460
- 5437
- 5213
- 5295
- 5302
- 5387
- 5468
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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