FDA Medical Device Recalls (openFDA)
Varian Medical Systems Inc: Varian Real-Time Position Management System (RPM), A Respiratory Gating System; Version 1.7.3, All Models; Varian Medical Systems, Palo Alto, CA 94304
- Recall number
- Z-0554-2008
- 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
- Status
- Terminated
- Initiated
- 2007-09-26
- Posted
- 2008-01-29
- Terminated
- 2009-09-30
- Reason
- 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
- 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
- 59 units
- Distribution
- Worldwide including countries of: Ireland, Italy, Spain, UK, Denmark, Finland, France, and Canada
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K063270"]
- PMA numbers
- not on file
- Product code
- IYE
- Firm FEI
- 2916710
- Firm city
- Palo Alto
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28