Philips Achieva MRI Patient Support Table Floor Plate Installation Defect
Philips is recalling 115 Achieva 1.5T MRI systems due to potential incorrect installation of the patient support table floor plate.
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 recall involves a risk-of-harm product (patient support medical equipment) where no injury has been reported. The FDA Class II classification reflects the seriousness of the structural installation defect without reported hospitalizations.
Plain-English summary
Philips North America LLC is recalling the Achieva 1.5T Conversion Magnetic Resonance System due to an installation issue with the patient support table floor plate.
The patient support table floor plate may be incorrectly installed on affected units. Approximately 115 units are affected. The affected systems have been distributed worldwide.
The recalled product
- Product
- Achieva 1.5T Conversion, Magnetic Resonance System.
- Manufacturer
- Philips North America Llc
- Affected units
- 115
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. 781283
- 781346
- UDI-DI n/a
- Serial No. 39025
- 8020
- 39027
- 39060
- 39016
- 39079
- 39022
- 39001
- 8467
- 39013
- 39006
- 39004
- 39007
- 39008
- 39011
- 39010
- 39012
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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