Philips Achieva 3.0T MRI System Patient Support Table Floor Plate Installation Defect
Philips has recalled 511 units of the Achieva 3.0T Magnetic Resonance System due to a potential installation defect in the patient support table floor plate, which could affect table stability and patient safety.
What this means for you
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 FDA Class II medical device recall affects 511 units of equipment that directly supports patients during diagnostic imaging. An incorrectly installed patient support table floor plate presents a risk of patient harm through potential table instability, meeting the criterion of risk-of-harm products where injury has not yet been reported.
Plain-English summary
Philips North America LLC is recalling the Achieva 3.0T Magnetic Resonance System due to a potential installation defect. The patient support table floor plate may be incorrectly installed on affected units, which could compromise the structural stability of the patient support component.
A total of 511 units have been recalled with worldwide distribution, including throughout the United States and more than 100 countries. The Achieva 3.0T is a diagnostic magnetic resonance imaging system used in healthcare facilities.
This is classified as an FDA Class II recall.
The recalled product
- Product
- Achieva 3.0T, Magnetic Resonance System.
- Manufacturer
- Philips North America Llc
- Category
- Medical Device — Medical Imaging
- Hazard
- improper-installation
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. 781177
- 781277
- 781278
- 781344
- 781345
- UDI-DI n/a
- Serial No. 17108
- 24070
- 24114
- 34066
- 24053
- 17235
- 17256
- 17244
- 17114
- 34028
- 38018
- 17049
- 17217
- 38033
Distribution
Distributed nationwide across the United States.
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