Vision RT AlignRT 3D Imaging System Recalled for Potential Use Error
Vision RT Inc. is recalling 55 AlignRT 3D surface imaging systems due to a potential use error when the external Gate Controller is turned on after software startup.
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: The recall involves a medical device used in radiotherapy where a use error could impact patient safety, but the source text does not report any injuries or illnesses, fitting the 'risk-of-harm products where injury has not yet been reported' criterion.
Plain-English summary
Vision RT Inc. is recalling 55 units of the AlignRT video-based three-dimensional (3D) surface imaging system. The device is used to image the skin surface of a patient in 3D before and during radiotherapy treatment. The recall is due to a potential use error that can occur when the external Gate Controller is turned ON after the Vision RT software has been opened.
The affected units were distributed nationwide and in the rest of the world. Specific serial numbers (internally referred to as PCR numbers) are listed in the official recall notice. The source text does not report any illnesses, injuries, or deaths associated with this recall.
Healthcare facilities should contact Vision RT Inc. for instructions on how to resolve the issue. Consumers should not use the affected devices until further notice.
The recalled product
- Product
- AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment.
- Manufacturer
- Vision Rt Inc
- Category
- Medical Device — Imaging System
- Hazard
- Affected units
- 55
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)
- Serial numbers (internally referred to as PCR numbers): USA: 247-018
- 247-039
- 247-040
- 247-053
- 247-060
- 247-061
- 247-062
- 247-063
- 247-068
- 247-071
- 247-075
- 247-076
- 247-078
- 247-081
- 247-083
- 247-096
- 247-099
- 247-100
- 247-101
- 247-102
Distribution
Distributed nationwide across the United States.
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