Varian Real-Time Position Management System (RPM), A Respiratory Gating System; Version 1.7.3, All Models; Varian Medica
FDA device recall Z-0554-2008 · posted 2008-01-29 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems Inc
- Reason for recall
- Erroneously Resetting: RPM System version 1.7.3, software failure can occur that affects the gated radiotherapy treatment when phase-based gating is used. RPM 1.7 erroneously resets the phase-based gating thresholds to system default during the treatment session, if the user accesses the Session options during the treatment session. This can lead to difference between the planned and delivered
- Action taken
- Varian sent an Urgent Medical Device Correction letter on September 26, 2007, to all its direct consignees, informing them that the RPM version 1.7 may reset the phase thresholds if Sessions options are accessed during treatment. A Service Representative will be scheduling a visit to user site to perform the modification requested to address the problem, when a corrected software version is available.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 59 units
- Distribution
- Worldwide including countries of: Ireland, Italy, Spain, UK, Denmark, Finland, France, and Canada
- Date initiated
- 2007-09-26
- Date posted
- 2008-01-29
- Date terminated
- 2009-09-30
- Location
- Palo Alto, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RPM RESPIRATORY GATING SYSTEM (K063270) | Varian Medical Systems, Inc. | 2006-12-14 |