Z-2181-2011

Varian Medical System TrueBeam system for stereotactic radiosurgery and radiotherapy. Model number H19

Name: Z-2181-2011 Varian Medical System TrueBeam system for stereotactic radiosurgery and radiotherapy. Model number H19
Creator: Varian Medical Systems, Inc. Oncology Systems
Published: 2011-04-05
License: https://open.fda.gov/license/

Varian Medical Systems, Inc. / initiated 2011-04-05 / Terminated / root cause: manufacturing process

FDA source

Varian Medical Systems, Inc. Oncology Systems began a recall of Varian Medical System TrueBeam system for stereotactic radiosurgery and radiotherapy. Model number H19 on 2011-04-05. The reason FDA records is "Position sensor failure mode may result in an inaccurate position calculation. 1. The video returned by one of the two cameras inside the Spectra is all white or all black, and the Spectra stops tracking. Or 2. Certain...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2181-2011
Status: Terminated
Initiated: 2011-04-05
Posted: 2011-05-10
Terminated: 2012-06-19
Recalling firm: Varian Medical Systems, Inc.
Product: Varian Medical System TrueBeam system for stereotactic radiosurgery and radiotherapy. Model number H19;
Product code: IYE Accelerator, Linear, Medical
Reason for recall: Position sensor failure mode may result in an inaccurate position calculation. 1. The video returned by one of the two cameras inside the Spectra is all white or all black, and the Spectra stops tracking. Or 2. Certain video intensities are not available on one of the two cameras. The image has abnormally abrupt transitions from dark to light portions, without the normal shades of gray.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Varian Urgent Medical Device Correction, Urgent Field Safety Notice letters were sent to all affected facilities by certified mail on April 5, 2011.
Quantity in commerce: 20
Distribution: Nationwide distribution.
Product codes and lots: Model number H19; Code numbers: H191011, H191019, H191027, H191033, H191012, H191021, H191028, H191037, H191013, H191023, H191030, H191043, H191016, H191025, H191031, H191045, H191018, H191026, H191032, H191047. Affected NDA Serial numbers: P7-03112, P7-03174, P7-03221.

Product code IYE

K092871Class IITrilogy MxVarian Medical Systems, Inc. / cleared 2009-11-30

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)