Recall Z-1163-2013 ยท IYE Accelerator, Linear, Medical
Varian Medical Systems, Inc. Oncology Systems
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 to characterize the patients respiratory motion information to synchronize their operation with the respiratory motion.
| Date | Apr 23, 2013 (initiated Mar 26, 2013) |
| Status | Terminated |
| 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 in amplitude and phase-gating sessions. |
| Root cause | Device Design |
| Action | Varian sent an Urgent Medical Device Correction - Urgent Field Safety Notice Letter dated March 26, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to retain a copy of this document along with their most current product labeling, advise the appropriate personnel of the content of this letter, and for future reference this document will be posted to the Varian Medical Systems customer support website: http://www.MyVarian.com. The letter stated that a Varian Medical Systems has developed a technical correc |
| Quantity | 2508 units |
| Distribution | Worldwide Distribution - USA (Nationwide) and countries of: Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Canada, China, Columbia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Estonia, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102024 | RPM RESPIRATORY GATING SYSTEM Varian Medical Systems, Oct 15, 2010 |