Philips Achieva 1.5T MRI System: Patient Support Table Floor Plate Installation Issue
Philips is recalling 69 units of the Achieva 1.5T Initial MRI system due to potential issues with the patient support table floor plate installation, which may affect patient safety during imaging.
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 involves a structural installation issue on patient-support equipment that could affect user safety. No illnesses or injuries have been reported. The score reflects the criteria for High severity: a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Philips North America LLC is recalling 69 units of the Achieva 1.5T Initial Magnetic Resonance System due to a potential installation issue with the patient support table floor plate.
The patient support table floor plate may be incorrectly installed in affected units. If not properly installed, this could compromise the safety and stability of the patient support system during MRI procedures.
The recalled units were distributed worldwide, including throughout the United States and to multiple countries across North America, Europe, Asia, Africa, and Oceania.
Healthcare facilities with affected units should contact Philips North America LLC for guidance on inspecting the patient support table floor plate installation and obtaining corrective measures.
The recalled product
- Product
- Achieva 1.5T Initial, Magnetic Resonance System.
- Manufacturer
- Philips North America Llc
- Category
- Medical Device — MRI System
- Hazard
- improper-installation
- structural-defect
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. 781178
- UDI-DI n/a
- Serial No. 20126
- 20129
- 20062
- 20297
- 20307
- 20150
- 20248
- 20096
- 20252
- 20257
- 20282
- 20149
- 20072
- 20277
- 20281
- 20185
- 20081
- 20018
Distribution
Distributed nationwide across the United States.
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