Magnetic Resonance System Patient Support Table Floor Plate May Be Incorrectly Installed
Philips is recalling 672 units of its SmartPath to dStream MRI system because the patient support table floor plate may be incorrectly installed, posing a patient 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 recall for a risk-of-harm medical device with no injuries reported. An incorrectly installed patient support structure poses a potential safety hazard, but the hazard is theoretical with no documented patient harm to date.
Plain-English summary
Philips North America LLC is recalling the SmartPath to dStream for 1.5T magnetic resonance imaging (MRI) system. This medical device is used in healthcare facilities for diagnostic imaging. A total of 672 units with model numbers 781260 and 782112 have been distributed worldwide, including to the United States and numerous international locations.
The patient support table floor plate on some of these systems may be incorrectly installed. An incorrectly installed floor plate poses a patient safety risk.
The FDA has classified this as a Class II medical device recall. Healthcare facilities and imaging centers with affected systems should contact Philips North America LLC for verification and correction procedures regarding the floor plate installation.
The recalled product
- Product
- SmartPath to dStream for 1.5T, Magnetic Resonance System.
- Manufacturer
- Philips North America Llc
- Affected units
- 672
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. 781260
- 782112
- UDI-DI 884838095076
- 884838098886
- Serial No. 8954
- 18726
- 32174
- 21664
- 8906
- 8578
- 10703
- 8835
- 10154
- 8971
- 20226
- 9001
- 21665
- 20204
- 21108
- 5475
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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