Recall Z-1163-2013— Varian Medical Systems, Inc. Oncology Systems
Class II · Terminated
Class II FDA medical device recall by Varian Medical Systems, Inc. Oncology Systems, initiated 2013-03-26, terminated 2014-07-09. It names one FDA 510(k) clearance: K102024. Product: 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.. 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..
- Recalling firm
- Varian Medical Systems, Inc. Oncology Systems
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-03-26
- Terminated
- 2014-07-09
- Firm location
- Palo Alto, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.