Quick Facts at a Glance
- Recall Date
- August 27, 2025
- Hazard Level
- HIGH
- Brand
- Vision RT
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Vision RT
- Product type
- Laser Tracking System
- Model numbers
- Part Number V000629
- Sold at
- Multiple Retailers
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
August 27, 2025
Reported by FDA DEVICE
January 14, 2026
RecallRadar source check
January 21, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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).
What You Should Do
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
About This Product
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.
Why This Is Dangerous
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.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
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.
Practical Guidance
How to identify if yours is affected
- Check the part number V000629 on your device.
- Review the Instructions for Use provided with your AlignRT InBore system.
- Contact Vision RT if you have questions about your device.
Where to find product info
The part number and other identifiers can usually be found on the device label or accompanying documentation.
What timeline to expect
Expect a timeline of 4-6 weeks for processing refunds or replacements.
If the manufacturer is unresponsive
- Document your communication attempts with Vision RT.
- Contact the FDA for further assistance if you do not receive a timely response.
How to prevent similar issues
- Ensure all safety information is included in the Instructions for Use when purchasing medical devices.
- Look for devices that comply with established safety standards.
Documentation advice
Keep records of all correspondence with Vision RT and any receipts related to the purchase of the device.
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Product Details
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.
Key Facts
- Recall date: August 27, 2025
- Class II device
- No injuries reported
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Safety Guide
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