Philips MRI Software Recall for Image Reconstruction Failure
Philips is recalling 91 MRI systems due to a software issue that can terminate examinations during image reconstruction if specific scan parameters are manually adjusted.
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: The recall is classified as FDA Class II, but the source text does not report any injuries, illnesses, or deaths, and the hazard is a functional software failure rather than a direct physical injury risk.
Plain-English summary
Philips North America LLC is recalling 91 units of the Evolution upgrade 1.5T and Evolution upgrade 3.0T MRI systems. The affected model numbers are 782116, 782148, 782117, and 782143. These systems were distributed worldwide, including across the United States and numerous international markets.
The recall is due to a software issue that can cause an examination to terminate during the image reconstruction process. This failure occurs if scan parameters are manually adjusted in a way that causes reconstruction requirements to exceed the available system memory. The source text does not report any injuries, illnesses, or deaths associated with this defect.
Healthcare facilities should contact Philips North America LLC for instructions on how to resolve the software issue. Patients who have undergone scans on these systems should consult their healthcare provider if they have concerns about the integrity of their imaging results.
The recalled product
- Product
- Evolution upgrade 1.5T and Evolution upgrade 3.0T; Model Numbers (REF): 1. 782116 (1.5T), 2. 782148 (1.5T), 3. 782117 (3.0T), 4. 782143 (3.0T);
- Manufacturer
- Philips North America Llc
- Category
- Medical Device — MRI Systems
- Hazard
- Affected units
- 91
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)
- 1. Model Numbers (REF): 782116 (1.5T)
- UDI-DI: 884838099722
- Serial Numbers: 41130
- 70284
- 41491
- 41196
- 41520
- 70068
- 41024
- 41025
- 41051
- 41139
- 41144
- 41286
- 41327
- 41349
- 41424
- 41432
- 41433
- 70099
Distribution
Distributed nationwide across the United States.
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