Imaging device alignment error in cross-reference line functionality
Philips' SmartPath to Ingenia Elition X imaging devices (model numbers 782118 and 782144) may experience alignment errors in the cross-reference line when reviewing images with the MobiView application. Sixteen units have been distributed worldwide.
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: Class II medical device recall with potential for alignment errors that could affect image review. No reported illnesses, injuries, or deaths. Per FDA guidelines, risk-of-harm products without reported injury receive a High severity rating.
Plain-English summary
Philips North America is recalling SmartPath to Ingenia Elition X medical imaging devices (model numbers 782118 and 782144) due to a potential for alignment errors in the cross-reference line functionality when reviewing images with the MobiView application.
Sixteen units of the affected devices were distributed worldwide, including throughout the United States and in multiple international locations. The FDA classified this as a Class II recall.
Users of these devices should contact Philips North America for further information or guidance regarding this recall.
The recalled product
- Product
- Product Name: SmartPath to Ingenia Elition X; Model Numbers: (1) 782118, (2) 782144;
- Manufacturer
- Philips North America Llc
- Hazard
- cross-reference-alignment-error
- image-review-error
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) 782118
- (2) 782144
- UDI-DI: (1) 00884838099746
- (2) 00884838108677
- Serial Numbers: (1) 42072
- 42194
- 42306
- 71019
- 71025
- 71050
- 85661
- 85676
- (2) 42062
- 42105
- 42323
- 42346
- 42441
- 71278
- 71504
- 71508
Distribution
Distributed nationwide across the United States.
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