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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 74585

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
June 23, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Varian Medical Systems, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

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.

Z-2149-2016
Recall number
Z-2149-2016
Initiated
June 23, 2016
Classification
Class II
Status
Terminated
Quantity
166 OSMS in US, 23 OSMO - International,

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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].

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

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].

Code information

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 HOM0304 HOM0305 HOM0306 HOM0307 HOM0308 HOM0309 HOM0310 HOM0311 HOM0312 HOM0313 HOM0314 HOM0315 HOM0316 HOM0317 HOM0318 HOM0319 HOM0320 HOM0321 HOM0322 HOM0323 HOM0324 HOM0329 HOM0330 HOM0331 HOM0332 HOM0333 HOM0334 HOM0335 HOM0336 HOM0337 HOM0338 HOM0339 HOM0340 HOM0341 HOM0342 HOM0347 HOM0348 HOM0349 HOM0350 HOM0351 HOM0352 HOM0353 HOM0354 HOM0356 HOM0357 HOM0358 HOM0359 HOM0360 HOM0361 HOM0362 HOM0363 HOM0364 HOM0365 HOM0366 HOM0367 HOM0368 HOM0369 HOM0370 HOM0371 HOM0372 HOM0373 HOM0374 HOM0381 HOM0382 HOM0383 HOM0386 HOM0387 HOM0388 HOM0389 HOM0390 HOM0391 HOM0392 HOM0393 HOM0394 HOM0395 HOM0396 HOM0403 HOM0404 HOM0405 HOM0406 HOM0409 HOM0410 HOM0411 HOM0412 HOM0413 HOM0414 HOM0415 HOM0416 HOM0420 HOM0421 HOM0422 HOM0424 HOM0440 HOM0441 HOM0442 HOM0444 HOM0445 HOM0447 HOM0448 HOM0454 HOM0457 HOMWMZ1.

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Austria, Azerbaijan, Brunei Darussalam, Bulgaria, Denmark, Georgia, Germany, India, Italy, Malaysia, Morocco, Norway, Portugal, Switzerland, and United Kingdom.

device · product 2 of 2

Optical Surface Monitoring System{Align RT Plus} 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.

Z-2150-2016
Recall number
Z-2150-2016
Initiated
June 23, 2016
Classification
Class II
Status
Terminated
Quantity
21 AlignRT Plus in US, 1 International.

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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].

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

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].

Code information

TrueBeam version 2.0/2.5 with any version OSMS. AlignRT Serial Numbers: 247-0200 247-0209 248-0013 248-0057 248-0070 249-0057 249-0066 249-0163 249-0164 249-0195 249-0226 249-0274 249-0050 249-0286 249-0277 248-0044 249-0227 247-0208 249-0047 247-0218 248-0050 248-0043 248-0048 249-0293 249-0155.

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Austria, Azerbaijan, Brunei Darussalam, Bulgaria, Denmark, Georgia, Germany, India, Italy, Malaysia, Morocco, Norway, Portugal, Switzerland, and United Kingdom.