FDA Device recall Z-2149-2016
Optical Surface Monitoring System{OSMS, Varian Private Label} This is used on Varian's TrueBeam EDGE
- FDA Device
- Class II
- terminated
- Published 2016-07-20
On 2016-07-20 the FDA classified a Class II recall of Optical Surface Monitoring System{OSMS, Varian Private Label} This is used on Varian's TrueBeam EDGE by Varian Medical Systems, citing 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 c….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2149-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-06-23 |
| Published | 2016-07-20 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Varian Medical Systems |
| Distribution | US |
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
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].
Identifiers
| code_info | TrueBeam version 2.0/2.5 with any version OSMS. OSMA serial numbers: HOM0084 HOM0176 HOM0368 HOM0003 HOM0004 H…TrueBeam version 2.0/2.5 with any version OSMS. OSMA serial numbers: HOM0084 HOM0176 HOM0368 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 HOM0031 HOM0032 HOM0033 HOM0034 HOM0035 HOM0036 HOM0037 HOM0071 HOM0072 HOM0073 HOM0074 HOM0075 HOM0076 HOM0077 HOM0078 HOM0079 HOM0080 HOM0081 HOM0082 HOM0083 HOM0084 HOM0085 HOM0086 HOM0087 HOM0088 HOM0089 HOM0090 HOM0091 HOM0095 HOM0096 HOM0097 HOM0098 HOM0099 HOM0100 HOM0101 HOM0102 HOM0103 HOM0107 HOM0108 HOM0109 HOM0110 HOM0111 HOM0113 HOM0114 HOM0115 HOM0116 HOM0117 HOM0118 HOM0125 HOM0126 HOM0127 HOM0128 HOM0129 HOM0170 HOM0171 HOM0172 HOM0173 HOM0174 HOM0175 HOM0176 HOM0177 HOM0178 HOM0179 HOM0180 HOM0181 HOM0182 HOM0183 HOM0184 HOM0185 HOM0186 HOM0187 HOM0188 HOM0189 HOM0190 HOM0191 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2149-2016%22
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