Varian brand RPM Respiratory Gating System — Class II medical device recall Z-1163-2013
Terminated recall by Varian Medical Systems, Inc. Oncology Systems, reported 2013-05-01, distributed nationwide. Varian has identified an anomaly with the RPM Respiratory Gating System version I.7.5 with 3D Option. While op
| Recall number | Z-1163-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, United States |
| Recall initiated | 2013-03-26 |
| Classified | 2013-04-23 |
| Reported by FDA | 2013-05-01 |
| Terminated | 2014-07-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BD, BE, BG, BR, CA, CH, CN, CR, CY, CZ, DE, DK, DO, EE, ES, FI, FR, GB, GR, GT, HK, HU, ID, IE, IL, IN, IT, JP, KR, KW, LB, LT, LU, LV, MA, MX, MY, NL, NO, NZ, PE, PL, PT, QA, RO, RU, SA, SE, SG, TH, TR, TW, UA |
| Quantity | 2,508 units |
| Model numbers | HS2 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1163-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.