Optical Surface Monitoring System{OSMS — Class II medical device recall Z-2149-2016
Terminated recall by Varian Medical Systems, Inc., reported 2016-07-20, distributed nationwide. Varian Medical Systems has received reports that unintended changes were made to planned couch parameters, spe
| Recall number | Z-2149-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Varian Medical Systems, Inc., Palo Alto, CA, United States |
| Recall initiated | 2016-06-23 |
| Classified | 2016-07-11 |
| Reported by FDA | 2016-07-20 |
| Terminated | 2018-08-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BG, CH, DE, DK, GB, IN, IT, MA, MY, NO, PT |
| Serial numbers | HOM0003, HOM0004, HOM0005, HOM0006, HOM0008, HOM0009, HOM0010, HOM0011, HOM0012, HOM0015, HOM0016, HOM0017, HOM0018, HOM0019, HOM0020, HOM0021, HOM0022, HOM0023, HOM0024, HOM0025, HOM0026, HOM0027, HOM0028, HOM0029, HOM0030 and 177 more |
Product
Optical Surface Monitoring System{OSMS, Varian Private Label} This is used on Varian's TrueBeam EDGE; Radiology: The 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.
Reason for recall
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].
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2149-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.