Varian RPM Respiratory Gating System Recall for Waveform Anomaly
Varian is recalling RPM Respiratory Gating System v1.7.5 units because they may produce inverted respiratory waveforms during specific sessions.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity score.
Plain-English summary
Varian Medical Systems, Inc. Oncology Systems is recalling 2,508 units of the Varian brand RPM Respiratory Gating System, version 1.7.5 with 3D Option, Model Number HS2. The device is used to characterize a patient's respiratory motion to synchronize operations with that motion.
The recall was initiated because Varian identified an anomaly where the system may produce an inverted respiratory waveform in amplitude and phase-gating sessions when operating with the 6-dot marker block. This defect could affect the accuracy of the respiratory gating data.
The affected units were distributed worldwide, including in the United States and numerous international markets. Users of this specific software version should contact Varian Medical Systems for instructions on how to resolve the issue.
The recalled product
- 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.
- Manufacturer
- Varian Medical Systems, Inc. Oncology Systems
- Affected units
- 2,508
Distribution
Distributed nationwide across the United States.
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