Reported Aug 31, 2016 · Terminated
AlignRT¿ Plus [private label-OSMS] K123371: The AlignRT Plus system is indicated for use to position and monitor…
Vision RT Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Vision RT Ltd · Dove House, Arcadia Avenue · London · N/A
Is this the product you have?
- AlignRT¿ Plus [private label-OSMS]
- K123371The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to withhold the beam automatically during radiation delivery
- Lot codes and dates
- Serial Number of the device(s) distributed
248-016248-021248-022248-030248-038248-041248-063248-064249-1514249-1516248-071249-0239248-073248-080248-084249-0043249-0055249-0056249-0058249-0069249-0130249-0137249-1509249-0141249-0275249-0152249-0162249-0169249-0251249-0253249-0254249-0288249-1503249-1512249-1518249-TBD249-0061249-0131249-0256249-0289249-0290249-TBD248-083249-0273249-0276249-1500249-1519
- Serial Number of the device(s) distributed
- Amount recalled
- 47
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Why it was recalled
Vision RT Ltd received three (3) reports from different sites that discovered the following issue, unintended changes were made to planned couch parameters, specifically the couch rotation parameter, during patient set-up for the Optical Surface Monitoring System [OSMS]. 1. CRM 3194, No Serious Injury, No MDR, Aware date: Dec 11, 2015 2. CRM 3321, No Patient Involved, No MDR, Aware date: Jan 19, 2016 3. CRM 4570, No Serious Injury, No MDR, Aware date: March 15, 2016 No patient harm was reported in any of these cases.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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