Z-0364-2012

TrueBeam and TrueBeam STx, Model Number: H19, Ref/FSCA identifier: CP-06381 are intended to provide...

Name: Z-0364-2012 TrueBeam and TrueBeam STx, Model Number: H19, Ref/FSCA identifier: CP-06381 are intended to provide...
Creator: Varian Medical Systems, Inc. Oncology Systems
Published: 2011-10-31
License: https://open.fda.gov/license/

Varian Medical Systems, Inc. / initiated 2011-10-31 / Terminated / root cause: design

FDA source

Varian Medical Systems, Inc. Oncology Systems began a recall of TrueBeam and TrueBeam STx, Model Number: H19, Ref/FSCA identifier: CP-06381 are intended to provide stereotactic radiosurgery and precision radiotherapy for... on 2011-10-31. The reason FDA records is "An anomaly has been identified with the TrueBeam and TrueBeam STx systems where, under certain tuning conditions, the electron beam emerging from the bend magnet may have an elongated spot shape". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0364-2012
Status: Terminated
Initiated: 2011-10-31
Posted: 2011-12-02
Terminated: 2012-07-25
Recalling firm: Varian Medical Systems, Inc.
Product: TrueBeam and TrueBeam STx, Model Number: H19, Ref/FSCA identifier: CP-06381 are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
Product code: -IYE
Reason for recall: An anomaly has been identified with the TrueBeam and TrueBeam STx systems where, under certain tuning conditions, the electron beam emerging from the bend magnet may have an elongated spot shape.
Root cause tag: design
FDA root cause: Device Design
Action: On 11/04/2011, an Urgent Medical Device Correction Letter was distributed to all affected users, with a description of the problem and user corrective action steps. Varian is developing a corrective action for this issue. A customer service representative will contact you when the correction is available to schedule installation on your system. Questions regarding the letter should be directed to the Varian Oncology Help Desk Contact Information at USA and Canada: 1-888-827- 4265 or Europe +41-41-749-8844.
Distribution: Worldwide distribution including the US and Internationally.
Product codes and lots: Model numbers: H191113, H191034, H191105, H191154, H191046, H191053, H191044, H191015, H191035, H191108, 191152, H191140, H191069, H191017, H191027, H191109, 191130, H191002, H191071, H191024, H191078, H191111, 191072, H191102, H191074, H191087, H191151, H191125, 191018, H191058, H191038, H191115, H191085, H191032, 191077, H191023, H191103, H191095, H191163, H191146, 191124, H191138, H191093, H191097, H191040, H191030, 191029, H191060, H191066, H191122, H191054, H191126, 191114, H191082, H191067, H191081, H191005, H191013, 191116, H191051, H191094, H191052, H191031, H191021, 191048, H191139, H191099, H191020, H191039, H191128, 191156, H191057, H191061, H191112, H191049, H191083, 191008, H191123, H191065, H191119, H191089, H191120, 191092, H191134, H191129, H191056, H191090, H191033, 191047, H191037, H191076, H191007, H191028, H191080, 191106, H191118, H191073, H191117, H191155, H191086, 191141, H191025, H191036, H191042, H191079, H191135, 191010, H191100, H191107, H191127, H191063, H191070, 191153, H191026, H191096, H191014, H191064, H191059, 191009, H191142, H191068, H191001, H191132, H191011, 191003, H191136, H191022, H191121, H191016, H191012, 191045, H191101, H191088, H191041, H191043, H191150, 191019, H191055, H191133, H191131, H191091, H191098, 191006 and H191110

Product code -IYE

K111106Class IITruebeamVarian Medical Systems, Inc. / cleared 2011-08-18

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)