Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Varian Real-Time Position Management System (RPM), A Respiratory Gating System; Version 1.7.3, All Models; Varian Medical Systems, Palo Alto, CA 94304

FDA Recall Z-0554-2008 · Posted 2008-01-29

Recalling FirmVarian Medical Systems Inc
Recall StatusTerminated
Product CodeIYE
Date Initiated2007-09-26
Date Terminated2009-09-30
Product Quantity59 units

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

Firm Action

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

Distribution Pattern

Worldwide including countries of: Ireland, Italy, Spain, UK, Denmark, Finland, France, and Canada

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K063270RPM RESPIRATORY GATING SYSTEMVarian Medical Systems, Inc. · 2006-12-14

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑