Philips Achieva XR MRI Systems Recalled for Software Memory Issue
Philips is recalling 15 Achieva XR MRI systems because a software issue can terminate examinations if scan parameters exceed system memory.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving a software defect that causes examination termination. No injuries or illnesses are reported, and the hazard is operational rather than a direct physical injury risk, fitting the Moderate criteria for low-risk or precautionary recalls.
Plain-English summary
Philips North America LLC is recalling 15 units of the Achieva XR MRI system (Model Numbers 781153 and 781253). The recall is due to a software issue that can terminate an examination during the image reconstruction process if scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.
The affected units were distributed worldwide, including the United States and numerous international locations. Specific serial numbers for the affected units are listed in the recall documentation.
Healthcare facilities should contact Philips for instructions on how to resolve the software issue. No injuries or illnesses have been reported in connection with this recall.
The recalled product
- Product
- Achieva XR; Model Numbers (REF): 1. 781153, 2. 781253;
- Manufacturer
- Philips North America Llc
- Category
- Medical Device — MRI System
- Affected units
- 15
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 (18)
- 1. Model Numbers (REF): 781153
- UDI-DI: N/A
- Serial Numbers: 23035
- 23003
- 23021
- 23028
- 2. Model Numbers (REF): 781253
- Serial Numbers: 35028
- 35068
- 35083
- 35074
- 35049
- 35004
- 35006
- 35011
- 35015
- 35050
- 35076
Distribution
Distributed nationwide across the United States.
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