Philips Achieva 3.0T MRI Patient Support Table Floor Plate May Be Incorrectly Installed
Philips is recalling one Achieva 3.0T for PET MRI system with a patient support table floor plate 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: Class II recall for a medical device with an installation defect affecting patient-facing equipment. No illnesses or injuries have been reported, but the incorrect installation of a patient support component poses a potential risk of harm to patients and staff. This 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 one Achieva 3.0T for PET Magnetic Resonance System (Model 781477, Serial Number 43006). The patient support table floor plate may be incorrectly installed on this unit.
The device was distributed worldwide, including throughout the United States and numerous other countries.
This is classified as a Class II recall by the FDA.
The recalled product
- Product
- Achieva 3.0T for PET, Magnetic Resonance System.
- Manufacturer
- Philips North America Llc
- Category
- Medical Device — MRI System
- Hazard
- Affected units
- 1
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 (3)
- Model No. 781477
- UDI-DI n/a
- Serial No. 43006.
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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