Philips MR 7700 MRI Systems Recalled for Software Issue
Philips is recalling 37 MR 7700 MRI systems due to a software issue that can terminate examinations 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 hospitalizations. The hazard is a software malfunction that terminates examinations, which fits the criteria for a moderate severity recall involving a risk of harm where injury has not yet been reported or is theoretical.
Plain-English summary
Philips North America LLC is recalling 37 units of the MR 7700 and Upgrade to MR 7700 MRI systems. The affected model numbers are 782120, 782153, and 782130. These devices were distributed worldwide, including in the United States and numerous international locations.
The recall is due to a software issue that will terminate an examination during the image reconstruction process if scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory. This issue affects the specific serial numbers listed in the recall documentation.
Healthcare facilities should contact Philips North America LLC for instructions on how to resolve the software issue. Patients and consumers should consult with their healthcare provider regarding any examinations performed on these devices.
The recalled product
- Product
- MR 7700 and Upgrade to MR 7700; Model Number (REF): 1. 782120, 2. 782153, 3. 782130 (Upgrade);
- Manufacturer
- Philips North America Llc
- Category
- Medical Device — MRI Systems
- Affected units
- 37
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): 782120
- UDI-DI: 884838104112
- Serial Numbers: 65002
- 65003
- 65014
- 65015
- 65050
- 65029
- 65056
- 65018
- 65021
- 65035
- 65038
- 65000
- 65025
- 65006
- 65008
- 65043
- 2. Model Number (REF): 782153
- UDI-DI: 884838112858
Distribution
Distributed nationwide across the United States.
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