Philips MR 5300 MRI Scanner Software Recall for Image Reconstruction Failure
Philips is recalling 611 MR 5300 MRI scanners due to a software issue that can terminate examinations during image reconstruction 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, which typically corresponds to a moderate severity where the hazard is unlikely to cause serious adverse health consequences but could cause temporary or medically reversible harm.
Plain-English summary
Philips North America LLC is recalling 611 units of the MR 5300 MRI scanner (Model Numbers 782110 and 782152). The recall is due to a software issue that can cause the system to terminate an examination 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 affected devices were distributed worldwide, including in the United States and numerous other countries. The recall is classified as Class II by the FDA, indicating that use of the product could, in some cases, cause temporary or medically reversible health consequences.
Healthcare facilities should contact Philips North America LLC for instructions on how to resolve the software issue. Patients who have undergone scans on these devices should consult their healthcare provider if they have concerns about the integrity of their imaging results.
The recalled product
- Product
- MR 5300 Model Number (REF): 1. 782110, 2. 782152;
- Manufacturer
- Philips North America Llc
- Category
- Medical Device — MRI Scanner
- Affected units
- 611
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 Number (REF): 782110
- UDI-DI: 884838099364
- Serial Numbers: 63383
- 63384
- 63385
- 63386
- 63422
- 63435
- 63643
- 63346
- 63021
- 63054
- 63091
- 63092
- 63113
- 63313
- 63314
- 63315
- 63322
- 63521
Distribution
Distributed nationwide across the United States.
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