Laser tracking system recalled over laser information omitted from instructions
Vision RT is recalling 56 AlignRT InBore systems because information identifying the lasers and their characteristics was omitted from the Instructions for Use.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: Scored 1 under the documentation criterion: the record cites information omitted from the instructions with no product defect or reported harm.
Plain-English summary
The AlignRT InBore system, part number V000629, is being recalled by Vision RT Ltd. The record states the system contains six Class 1 lasers which enable its cameras to track the patient's position and movement.
Vision RT is informing customers of an omission identified in the Instructions for Use for AlignRT InBore systems. Information identifying the lasers and their characteristics was omitted from the Instructions for Use as required by 21 CFR 1040.10(h), via conformance with the recognized consensus standard IEC 60825-1 Ed. 3.
The record lists 56 units. Distribution was in the United States and outside it. The FDA has classified the action as Class II.
The enforcement record describes an omission in the documentation rather than a product defect, and reports no injuries. Facilities should follow Vision RT's instructions.
The recalled product
- Product
- The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement.
- Manufacturer
- Vision RT Ltd
- Hazard
- documentation
- instructions-omission
- laser-labeling
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 (1)
- Part Number V000629
Distribution
Distribution scope not specified by the agency.
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