Philips MRI Systems Recalled Due to Incorrectly Installed Patient Table Floor Plate
Philips is recalling 33 Enterprise 1.5T MRI systems due to patient support table floor plates that may be incorrectly installed.
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 medical device recall involving a structural installation defect on a patient-support component. Although no injuries have been reported and the agency classified it as Class II, it meets the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Philips North America LLC is recalling 33 units of the Enterprise 1.5T Magnetic Resonance System due to an issue with the patient support table floor plate.
The patient support table floor plate may be incorrectly installed on affected units. This defect could pose a risk to patients during equipment use.
The affected systems have been distributed worldwide, including throughout the United States and internationally. Facilities with affected systems should verify the installation of the patient support table floor plate and contact Philips North America LLC for instructions on corrective actions if their unit is involved.
The U.S. Food and Drug Administration classified this as a Class II recall.
The recalled product
- Product
- Enterprise 1.5T, Magnetic Resonance System.
- Manufacturer
- Philips North America Llc
- Category
- Medical Device — MRI System
- Affected units
- 33
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. 781145
- UDI-DI n/a
- Serial No. 10709
- 10682
- 10678
- 10729
- 10217
- 10031
- 10092
- 10111
- 10715
- 10074
- 10121
- 10122
- 10119
- 10732
- 10775
- 10795
- 10041
- 10711
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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