Z-0978-2007

LINAC Scapel Treatment Planning System, incorporating FastPlan software versions 4.0, 5.0, 5.0.1, 5.1, 5.1.1

Name: Z-0978-2007 LINAC Scapel Treatment Planning System, incorporating FastPlan software versions 4.0, 5.0, 5.0.1, 5.1, 5.1.1
Creator: Varian Medical Systems Inc
Published: 2007-03-09
License: https://open.fda.gov/license/

Varian Medical Systems, Inc. / initiated 2007-03-09 / Terminated / root cause: software

FDA source

Varian Medical Systems Inc began a recall of LINAC Scapel Treatment Planning System, incorporating FastPlan software versions 4.0, 5.0, 5.0.1, 5.1, 5.1.1 on 2007-03-09. The reason FDA records is "A software anomaly in a medical device used for patient treatment could result in accidental or unintended exposure radiation exposure. The tilt rotation compensation algorithm does not adequately compensate for the...". 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-0978-2007
Status: Terminated
Initiated: 2007-03-09
Posted: 2007-06-28
Terminated: 2012-02-28
Recalling firm: Varian Medical Systems, Inc.
Product: LINAC Scapel Treatment Planning System, incorporating FastPlan software versions 4.0, 5.0, 5.0.1, 5.1, 5.1.1.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: A software anomaly in a medical device used for patient treatment could result in accidental or unintended exposure radiation exposure. The tilt rotation compensation algorithm does not adequately compensate for the tilt rotation.
Root cause tag: software
FDA root cause: Software design
Action: The recalling firm notified medical device end users by letter dated 03/09/07 and advised of the software anomaly and provided details for user corrective action pending software upgrade by the manufacturer.
Quantity in commerce: 80 devices
Distribution: The medical devices were distributed to medical centers nationwide and worldwide.
Product codes and lots: S/Ns: HZ30001 HZ30020 HZ30021 HZ30033 HZ30054 HZ30061 HZ30108 HZ30139 HZ30144 HZ30167 HZ30171 HZ30178 HZ30207 HZ30208 HZ30224 HZ30230 HZ30251 HZ30265 HZ30280 HZ30283 HZ30293 HZ30294 HZ30299 HZ30312 HZ30330 HZ30342 HZ30349 HZ30368 HZ30398 HZ30403 HZ30404 HZ30407 HZ30422 HZ30426 HZ30460 HZ30461 HZ30462 HZ30485 HZ30495 HZ30507 HZ30508 HZ30509 HZ30511 HZ30513 HZ30520 HZ30531 HZ30537 HZ30540 HZ30556 HZ30557 HZ30571 HZ30572 HZ30573 HZ30574 HZ30588 HZ30604 HZ30612 HZ30617 HZ30620 HZ30640 HZ30646 HZ30649 HZ30656 HZ30670 HZ30674 HZ30675 HZ30681 HZ30684 HZ30698 HZ30703 HZ30727 HZ30731 HZ30740 HZ35070 HZ39020 HZ39066 HZ39071 HZ39165 HZ39997

Product code IYE

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)