Z-0554-2008

Varian Real-Time Position Management System (RPM), A Respiratory Gating System; Version 1.7.3, All Models...

Name: Z-0554-2008 Varian Real-Time Position Management System (RPM), A Respiratory Gating System; Version 1.7.3, All Models...
Creator: Varian Medical Systems Inc
Published: 2007-09-26
License: https://open.fda.gov/license/

Varian Medical Systems, Inc. / initiated 2007-09-26 / Terminated / root cause: software

FDA source

Varian Medical Systems Inc began a recall of Varian Real-Time Position Management System (RPM), A Respiratory Gating System; Version 1.7.3, All Models; Varian Medical Systems, Palo Alto, CA 94304 on 2007-09-26. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0554-2008
Status: Terminated
Initiated: 2007-09-26
Posted: 2008-01-29
Terminated: 2009-09-30
Recalling firm: Varian Medical Systems, Inc.
Product: Varian Real-Time Position Management System (RPM), A Respiratory Gating System; Version 1.7.3, All Models; Varian Medical Systems, Palo Alto, CA 94304
Product code: IYE Accelerator, Linear, Medical
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
Root cause tag: software
FDA root cause: Software design
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.
Quantity in commerce: 59 units
Distribution: Worldwide including countries of: Ireland, Italy, Spain, UK, Denmark, Finland, France, and Canada
Product codes and lots: Serial Number: H502244, H502211, H502203, H502183, H502179, H502178, H502169, H502167, H502166, H502154, H502152, H502138, H502137, H502136, H502133, H502132, H502131, H502130, H502126, H502121, H502119, H502118, H502117, H502116, H502112, H502110, H502107, H502104, H502103, H502102, H502096, H502060, H502057, H502045, H502002, H501999, H501983, H501930, H501907, H501904, H501869, H501838, H501577, H501412, H501367, H501329, H501325, H501306, H501290, H501259, H501246, H501222, H501214, H502051, H502067, H500395, H500406, H500853, and H502066

Product code IYE

K063270Class IIRpm Respiratory Gating SystemVarian Medical Systems, Inc. / cleared 2006-12-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)