Reported Jul 20, 2016 · Terminated
Optical Surface Monitoring System{OSMS, Varian Private Label} This is used on Varian's TrueBeam EDGE; Radiology: The…
Varian Medical Systems, Inc.
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: Varian Medical Systems, Inc. · 911 Hansen Way · Palo Alto, CA · 94304-1028
Is this the product you have?
- Optical Surface Monitoring System{OSMS, Varian Private Label} This is used on Varian's TrueBeam EDGE
- RadiologyThe 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
- TrueBeam version 2.0/2.5 with any version OSMS
- OSMA serial numbers
205 of 205 codes
HOM0084HOM0176HOM0368HOM0003HOM0004HOM0005HOM0006HOM0008HOM0009HOM0010HOM0011HOM0012HOM0015HOM0016HOM0017HOM0018HOM0019HOM0020HOM0021HOM0022HOM0023HOM0024HOM0025HOM0026HOM0027HOM0028HOM0029HOM0030HOM0031HOM0032HOM0033HOM0034HOM0035HOM0036HOM0037HOM0071HOM0072HOM0073HOM0074HOM0075HOM0076HOM0077HOM0078HOM0079HOM0080HOM0081HOM0082HOM0083HOM0084HOM0085HOM0086HOM0087HOM0088HOM0089HOM0090HOM0091HOM0095HOM0096HOM0097HOM0098
- Amount recalled
- 166 OSMS in US, 23 OSMO - International,
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- GA
Why it was recalled
Varian Medical Systems has received reports that unintended changes were made to planned couch parameters, specifically the couch rotation parameter, during patient set-up. This can occur when a user sets a different couch rotation from the plan couch rotation while performing patient alignment with Optical Surface Monitoring System [OSMS].
This product could cause temporary or reversible health problems — stop using it.
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