MRI system patient support table floor plate installation defect
Philips MRI systems may have an incorrectly installed patient support table floor plate, creating a potential stability risk during patient imaging.
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: This is a Class II recall involving a structural installation defect on critical patient-support equipment that creates risk of patient harm through potential loss of table stability. No injuries or illnesses have been reported, meeting the rubric criterion: 'risk-of-harm products where injury has not yet been reported' = High.
Plain-English summary
This recall affects 41 units of the SmartPath to dStream for XR and 3.0T Magnetic Resonance System manufactured by Philips North America LLC.
The patient support table floor plate may be incorrectly installed, which could compromise the stability and safety of the patient support table during use. This is a Class II recall.
Affected units have been distributed worldwide, including throughout the United States and over 100 additional countries. Specific affected model numbers, UDI-DI codes, and serial numbers are available through the FDA recall notice.
Healthcare facilities operating affected MRI systems should contact Philips North America LLC to verify proper floor plate installation and obtain corrective action instructions.
The recalled product
- Product
- SmartPath to dStream for XR and 3.0T, Magnetic Resonance System.
- Manufacturer
- Philips North America Llc
- Affected units
- 41
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. 781270
- 782113
- 782129
- UDI-DI 884838098909
- 884838105805
- Serial No. 17271
- 38281
- 17560
- 17252
- 34202
- 34153
- 34127
- 38311
- 34128
- 34172
- 17470
- 34131
- 24021
- 24093
- 17258
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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