Philips Achieva 1.5T MRI Systems Recalled for Software Memory Issue
Philips is recalling 387 Achieva 1.5T MRI systems worldwide because a software issue may terminate examinations if manual scan adjustments 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: The recall is classified as FDA Class II, which typically corresponds to a moderate severity where the use of the product may cause temporary or medically reversible health consequences. The specific hazard is a software termination of an examination, which is a functional defect rather than a direct physical injury or life-threatening condition.
Plain-English summary
Philips North America LLC is recalling 387 units of the Achieva 1.5T, Achieva 1.5T Conversion, and Achieva 1.5T Initial MRI systems. The recall covers specific model numbers and serial numbers distributed in the United States and numerous countries worldwide.
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.
Healthcare facilities and users of these systems should contact Philips for instructions on how to resolve the software issue. The source text does not specify a particular action for patients, but the defect affects the operational stability of the imaging equipment during specific manual adjustments.
The recalled product
- Product
- Achieva 1.5T, Achieva 1.5T Conversion and Achieva 1.5T Initial system; Model Numbers (REF): 1. 781196 (Achieva 1.5T), 2. 781343 (Achieva 1.5T), 3. 781283 (Achieva 1.5T Conversion), 4. 781346 (Achieva 1.5 Conversion), 5. 781178 (Achieva 1.5T Initial System);
- Manufacturer
- Philips North America Llc
- Category
- Medical Device — MRI Systems
- Affected units
- 387
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): 781196 (Achieva 1.5T)
- UDI-DI: N/A
- Serial Numbers: 22135
- 21807
- 22149
- 22162
- 22186
- 22264
- 21329
- 21787
- 21989
- 22022
- 22150
- 22180
- 22270
- 21674
- 22080
- 21190
- 21254
- 21315
Distribution
Distributed nationwide across the United States.
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