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RPM Respiratory Gating System
- Starting date:
- March 25, 2013
- Posting date:
- April 29, 2013
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-28929
Recalled Products
- RPM Respiratory Gating System
Reason
Varian has identified an anomaly with the RPM Respiratory Gating System version 1.7.5 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.
Affected products
A. RPM Respiratory Gating System
Lot or serial number
- More than 10 numbers, contact manufacturer
Model or catalog number
- 100012503-01
Companies
- Manufacturer
-
Varian Medical Systems, Inc.
3100 Hansen Way
Palo Alto
94304
California
UNITED STATES