SmartPath to dStream 3.0T Medical Device Recall for Software Error
Philips is recalling the SmartPath to dStream 3.0T medical device due to potential alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application. This could affect image interpretation accuracy.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall involving a software functionality error that could affect diagnostic image interpretation. Although no reported injuries or illnesses are stated in the source, the potential for misalignment in image review represents a risk of harm in a diagnostic imaging context, meeting the High threshold.
Plain-English summary
Philips North America LLC is recalling the SmartPath to dStream for 3.0T (Model Number 782145) due to potential alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
The alignment errors could impact the accuracy of image review and interpretation, potentially affecting clinical decision-making based on those images.
The recalled device has been distributed worldwide, including in the United States and numerous countries. A total of 12 units were distributed outside the United States. The affected devices have specific serial numbers: 17377, 17385, 34114, 34208, 38118, 38170, 38294, 38313, 38336, 73002, 73004, and 74004.
Healthcare facilities or individuals using this device should contact Philips North America LLC for further guidance on remediation or device status.
The recalled product
- Product
- Product Name: SmartPath to dStream for 3.0T; Model Number: 782145
- Manufacturer
- Philips North America Llc
- Affected units
- 12
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 (14)
- Model Number: 782145
- UDI-DI: 00884838095083
- Serial Numbers: 17377
- 17385
- 34114
- 34208
- 38118
- 38170
- 38294
- 38313
- 38336
- 73002
- 73004
- 74004
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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