Philips Ingenia Ambition MRI Software Recall for Memory Limit Issue
Philips is recalling 922 Ingenia Ambition MRI systems due to a software issue that can terminate examinations if system memory is exceeded.
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, and the source text does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity score.
Plain-English summary
Philips North America LLC is recalling 922 units of the Ingenia Ambition S and Ingenia Ambition X MRI systems. The affected model numbers are 781359, 782108, and 782139 for the S series, and 781356, 782109, and 782138 for the X series. These devices were distributed worldwide, including in 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 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 issue.
Healthcare facilities should contact Philips North America LLC for instructions on how to resolve the software issue. Patients and consumers should consult their healthcare providers regarding the status of any MRI examinations performed on these devices.
The recalled product
- Product
- Ingenia Ambition S and Ingenia Ambition X; Model Numbers (REF): 1. 781359 (S), 2. 782108 (S), 3. 782139 (S), 4. 781356 (X), 5. 782109 (X), 6. 782138 (X);
- Manufacturer
- Philips North America Llc
- Category
- Medical Device — MRI Systems
- Affected units
- 922
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): 781359(S)
- UDI-DI: 884838090057
- Serial Numbers: 48053
- 48126
- 48136
- 48144
- 48020
- 48030
- 48155
- 48191
- 48216
- 48218
- 48245
- 48300
- 48183
- 48186
- 48187
- 48222
- 48225
- 48234
Distribution
Distributed nationwide across the United States.
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