Philips SmartPath to dStream 1.5T medical device alignment recall
Philips is recalling certain SmartPath to dStream 1.5T medical imaging devices due to potential alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is a potential alignment error in image review functionality, which is a software or display issue rather than a direct safety threat, qualifying it as a moderate precautionary recall.
Plain-English summary
Philips North America LLC is recalling 80 units of the SmartPath to dStream for 1.5T medical imaging device, with model numbers 781260, 782112, and 782146. The devices are affected by a potential alignment error in the cross reference line functionality that may occur when reviewing images generated with the MobiView application.
The affected devices were distributed worldwide, including 1 unit in the US and 79 units outside the US, across numerous countries. Users of these specific model numbers and serial numbers should consult the device documentation and contact Philips for guidance on the cross reference line functionality issue.
This is a Class II recall issued by the U.S. Food and Drug Administration. Customers should not discard their devices but should contact Philips North America LLC for further instructions regarding assessment and any necessary corrective measures.
The recalled product
- Product
- Product Name: SmartPath to dStream for 1.5T; Model Numbers: (1) 781260, (2) 782112, (3) 782146
- Manufacturer
- Philips North America Llc
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)
- Model Numbers: (1) 781260
- (2) 782112
- (3) 782146
- UDI-DI: (1) 00884838095076
- (2) 00884838098886
- (3) 00884838108691
- Serial Numbers: (1) 10044
- 10151
- 10164
- 10170
- 11000
- 11001
- 11062
- 11076
- 12009
- 18038
- 18663
- 18872
- 18938
- 20115
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 18 recalled by Philips North America Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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