SmartPath dStream 3.0T upgrades recalled over elastography stiffness errors
Philips North America is recalling 1 unit of the SmartPath to dStream for 3.0T because exported MR Elastography stiffness maps may show stiffness value errors.
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: Scored 3 under the risk-of-harm criterion: the firm states exported elastography maps may show incorrect stiffness values, and no injuries are reported.
Plain-English summary
The Philips SmartPath to dStream for 3.0T, product code 782145, covering MR systems with software versions R11.1 and R12.1, is being recalled by Philips North America.
The reason given in the enforcement record is the potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps in a viewer Picture Archiving and Communication System (PACS).
The record lists 1 unit, with UDI-DI codes and serial numbers recorded in the enforcement record. Distribution was worldwide, including nationwide in the United States across the states listed in the record. The FDA has classified the action as Class II.
An incorrect stiffness value is a measurement a clinician reads. The enforcement record reports no injuries. Facilities should follow Philips' instructions.
The recalled product
- Product
- SmartPath to dStream for 3.0T. Product Code (REF): 782145. MR systems with SW version R11.1 and R12.1.
- Manufacturer
- Philips North America
- Category
- Medical Device — MRI
- Affected units
- 1
Distribution
Part of a larger recall action
This product is one of 13 recalled by Philips North America 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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