Vision RT recalled 56 AlignRT InBore systems on August 27, 2025, due to missing safety information in the Instructions for Use. The omission pertains to the identification and characteristics of the system's Class 1 lasers as required by federal regulations. Users must stop using the device immediately and follow manufacturer instructions.
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 for the subject system as required by 21 CFR 1040,10(h), via conformance with recognized consensus standard IEC 60825-1 Ed. 3 (FDA Laser Notice 56).
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Vision RT Ltd or your healthcare provider for instructions
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The AlignRT InBore system is a medical device designed for tracking patient position during procedures using laser technology. Healthcare providers use it to enhance precision in treatments that require accurate patient alignment.
The omission in the Instructions for Use regarding laser identification may lead to improper operation of the device. This can potentially compromise patient safety during medical procedures.
This recall is not part of a broader industry pattern.
Patients and healthcare providers must cease using the device to avoid potential risks associated with the omission. This may cause delays in treatment and the need for alternative solutions.
The part number and other identifiers can usually be found on the device label or accompanying documentation.
Expect a timeline of 4-6 weeks for processing refunds or replacements.
Keep records of all correspondence with Vision RT and any receipts related to the purchase of the device.
The AlignRT InBore system, part number V000629, includes six Class 1 lasers for patient tracking. It was distributed in the U.S. and internationally. The quantity recalled is 56 units.
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