MRI System Patient Support Table Floor Plate May Be Incorrectly Installed
Philips has recalled 2 Intera 1.5T MRI systems due to potential incorrect installation of the patient support table floor plate.
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 an FDA Class II medical device recall involving a physical installation defect that poses a potential safety hazard. No illnesses or injuries have been reported. Per the severity rubric, this qualifies as 'High' as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Philips North America LLC is recalling 2 units of the Intera 1.5T Achieva IT Nova Magnetic Resonance System (Model No. 781175, serial numbers 15002 and 15003). The patient support table floor plate may be incorrectly installed on these units.
An incorrectly installed floor plate poses a potential safety hazard that could affect the safe operation and use of the equipment.
The affected units were distributed worldwide, including throughout the United States and to numerous countries. Healthcare facilities that have received these units should contact Philips North America LLC regarding inspection and correction of the installation.
The recalled product
- Product
- Intera 1.5T Achieva IT Nova, Magnetic Resonance System.
- Manufacturer
- Philips North America Llc
- Affected units
- 2
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 (4)
- Model No. 781175
- UDI-DI n/a
- Serial No. 15002
- 15003.
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.
See all 41 products in this recall →Related recalls
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