Varian Medical Systems Oncology Systems recalls

Varian Medical Systems Oncology Systems appears in 9 official U.S. recall notices indexed by RecallRadar, most recently on 2013-05-22.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

Recall summary

Recalls

• Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System, Model Numbers: H14, H27, H29, HCX. Product Usage: The Vari…
  FDA Device · Class II · 2013-05-22 · Varian Medical Systems Oncology Systems
  Reason: Under certain conditions, photon beams in High Energy Clinacs may experience a gradual change in beam symmetry, potentially reaching an asymmetry of up to about 7% before interlock occurs. At maximum asymmetry, this may…
• Varian brand RPM Respiratory Gating System, RPM Gating v1.7.5 with 3D Option, Model Number: HS2 Product Usage: The RPM device is to be used…
  FDA Device · Class II · 2013-05-01 · Varian Medical Systems Oncology Systems
  Reason: Varian has identified an anomaly with the RPM Respiratory Gating System version I.7.5 with 3D Option. While operating with the 6-dot marker block, this version of RPM Gating may produce an inverted respiratory waveform…
• Varian Eclipse Treatment Planning System for Radiotherapy
  FDA Device · Class II · 2013-02-27 · Varian Medical Systems Oncology Systems
  Reason: The calculation of dose dynamic plans containing different energy fields is incorrect when the Pencil Beam Convolution 11.0 algorithm (PBC 11.0) is used.
• Varian brand ARIA Radiation Oncology, ARIA Oncology Information System Radiation Oncology, Import Export Application, Model Number: HIT, Af…
  FDA Device · Class II · 2012-12-26 · Varian Medical Systems Oncology Systems
  Reason: Varian Medical Systems has identified an anomaly with the ARIA Oncology Information System Radiation Oncology [ARIA RO] DICOM import/export functionality where a 360 degree arc field may convert to static field during D…
• ARIA Radiation Oncology, Version 11
  FDA Device · Class II · 2012-11-07 · Varian Medical Systems Oncology Systems
  Reason: An anomaly has been identified with the ARIA Oncology Information System Version 11 where Monitor Units of one fraction may be incorrect, when partial treatment is being continued.
• Varian brand Eclipse Treatment Planning System, Model Number: H48
  FDA Device · Class II · 2012-10-03 · Varian Medical Systems Oncology Systems
  Reason: Varian has identified an anomaly with the Eclipse Treatment Planning where an outdated assigned Hounsfield Unit [HU] value can be used for dose calculation when the clock on the Eclipse Client Workstation is not synchro…
• Varian brand Clinac, Trilogy, Novalis Tx, Unique, linear accelerators
  FDA Device · Class II · 2012-09-26 · Varian Medical Systems Oncology Systems
  Reason: Some X-jaw (lower collimator jaw) carriers were made using the incorrect metal alloy, which can cause the jaw carrier to crack. If both carriers on the same X-jaw crack, the jaw would be able to move freely in the close…
• Varian brand Varian ARIA Oncology Information System, Import Export application, v 11.0
  FDA Device · Class II · 2012-08-15 · Varian Medical Systems Oncology Systems
  Reason: A software anomaly has been identified with the Import Export Application version 11.0 where MLC leaf positions for plans using BrainLab m3 and mMLC are incorrectly imported.
• Varian brand Varian Eclipse Treatment Planning System for radiotherapy
  FDA Device · Class II · 2012-07-25 · Varian Medical Systems Oncology Systems
  Reason: Varian has identified an anomaly with the Eclipse Treatment Planning (for radiotherapy treatments) where changing the prescription in a calculated VMAT or RapidArc plan may lead to Monitor Units which do not reflect the…