FDA Device recall Z-1163-2013
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…
- FDA Device
- Class II
- terminated
- Published 2013-05-01
On 2013-05-01 the FDA classified a Class II recall of 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… by Varian Medical Systems Oncology Systems, citing 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 p….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1163-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-03-26 |
| Published | 2013-05-01 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Varian Medical Systems Oncology Systems |
| Distribution | US |
Product
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 patients respiratory motion information to synchronize their operation with the respiratory motion.
Reason
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 respiratory waveform in amplitude and phase-gating sessions.
Identifiers
| code_info | CODES: HS00017 HS00366 HS00611 HS00804 HS01060 HS01256 HS01451 HS01662 HS01863 HS02024 HS02215 HS02371 HS02539 HS00…CODES: HS00017 HS00366 HS00611 HS00804 HS01060 HS01256 HS01451 HS01662 HS01863 HS02024 HS02215 HS02371 HS02539 HS00018 HS00371 HS00615 HS00805 HS01061 HS01260 HS01456 HS01664 HS01872 HS02035 HS02239 HS02373 HS02542 HS00025 HS00378 HS00618 HS00806 HS01062 HS01265 HSOI459 HSOI667 HSOI875 HS02040 HS02240 HS02376 HS02545 HS00026 HS00384 HS00619 HS00807 HSOI063 HSOI269 HSOI460 HSOI671 HSOI876 HS02043 HS02242 HS02377 HS02548 HS00031 HS00385 HS00624 HS00811 HSOI066 HS01270 HSOI462 HSOI674 HSOI877 HS02048 HS02245 HS02380 HS02SSI HS00032 HS00392 HS00628 HS00813 HS01069 HSOI281 HS01463 HSOI675 HSOI878 HS02053 HS02250 HS02381 HS02553 HS00035 HS00393 HS00630 HS00814 HS01071 HSOI282 HS01466 HS01676 HS01883 HS020SS HS022Sl HS02383 HS02554 HS00036 HS00396 HS00634 HSOOSIS HS01080 HS01283 HS0147l HS01678 HS01885 HS02059 HS02253 HS02384 HS02SSS HS00037 HS00398 HS00636 HS00818 HSOIOSS HS01285 HS01480 HS01685 HS01886 HS02068 HS02256 HS02389 HS02562 HS00038 HS00408 HS00638 HS00827 HS01090 HS012 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1163-2013%22
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