Drug recall
Varian brand RPM Respiratory Gating System, RPM Gating v1.7.5 with 3D Option, Model Number: HS2 Product Usage…
FDA recall event 64828 · Class II · Varian Medical Systems, Inc. Oncology Systems
Key facts
| Event ID | 64828 |
|---|---|
| Recall numbers | Z-1163-2013 |
| Recalling firm | Varian Medical Systems, Inc. Oncology Systems |
| Product type | Devices |
| Products | 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 patient s respiratory motion information… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Mar 26, 2013 |
| Report date | May 1, 2013 |
| Termination date | Jul 9, 2014 |
| City | Palo Alto |
| State | CA |
| Country | United States |
| FEI number | 2916710 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: