Philips Achieva 3.0T MRI Software Recall for Memory Limit Issues
Philips is recalling 210 Achieva 3.0T MRI scanners because a software issue can terminate examinations if system memory is exceeded during image reconstruction.
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 software termination of the examination rather than a direct physical injury mechanism.
Plain-English summary
Philips North America LLC is recalling 210 units of the Achieva 3.0T MRI scanner, including model numbers 781177, 781277, 781278, 781344, and 781345. The recall is due to a software issue that can cause an examination to terminate during the image reconstruction process. This occurs if scan parameters are manually adjusted in a way that causes reconstruction requirements to exceed the available system memory.
The affected devices were distributed worldwide, including in the United States and numerous international markets. The source text does not report any specific injuries, illnesses, or deaths associated with this software issue. The hazard is limited to the interruption of the imaging procedure under specific manual adjustment conditions.
Healthcare facilities and users should contact Philips North America LLC for instructions on how to resolve the software issue. The recall is classified as FDA Class II, indicating a reasonable probability that the use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Achieva 3.0T; Model Numbers (REF): 1. 781177, 2. 781277, 3. 781278, 4. 781344, 5. 781345;
- Manufacturer
- Philips North America Llc
- Category
- Medical Device — MRI Scanner
- Hazard
- Affected units
- 210
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): 781177
- UDI-DI: N/A
- Serial Numbers: 17144
- 17376
- 17448
- 24049
- 17099
- 24138
- 24060
- 17607
- 17079
- 17146
- 17189
- 17379
- 17469
- 17270
- 17432
- 17279
- 17233
- 17295
Distribution
Distributed nationwide across the United States.
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