Z-2643-2011

ONCOR Impression, camera imaging system, Part Number: 5857920; Product is manufactured and distributed by...

Name: Z-2643-2011 ONCOR Impression, camera imaging system, Part Number: 5857920; Product is manufactured and distributed by...
Creator: Siemens Medical Solutions USA, Inc - Radiation Oncology
Published: 2010-11-04
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2010-11-04 / Terminated

FDA source

Siemens Medical Solutions USA, Inc - Radiation Oncology began a recall of ONCOR Impression, camera imaging system, Part Number: 5857920; Product is manufactured and distributed by SIEMENS MEDICAL SOLUTIONS USA, INC. Concord, CA; and... on 2010-11-04. The reason FDA records is "The firm has become aware of a potential issue that may result in a service engineer receiving an electrical shock should the connector cable housing become unfastened from the chassis". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2643-2011
Status: Terminated
Initiated: 2010-11-04
Posted: 2011-06-23
Terminated: 2011-11-14
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: ONCOR Impression, camera imaging system, Part Number: 5857920; Product is manufactured and distributed by SIEMENS MEDICAL SOLUTIONS USA, INC. Concord, CA; and SIEMENS AG, MEDICAL SOLUTIONS Roentgenstrasse, Kemnath, GERMANY, and SIEMENS AG, MEDICAL SOLUTIONS Henkestrasse, Erlangen, GERMANY The intended use of the SIEMENS branded linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: The firm has become aware of a potential issue that may result in a service engineer receiving an electrical shock should the connector cable housing become unfastened from the chassis.
FDA root cause: Other
Action: The firm, SIEMENS, sent a "Customer Information" letter to its customers on November 4, 2010. The letter describes the product, problem and actions to be taken. The customers were instructed to include this letter in their BEAMVIEW TI System Owner Manual chapter "Safety Advisory Letters" where it should remain. Siemens has developed an updated kit to install an additional grounding cable on the camera's central control unit to eliminate the problem. The updated kit was delivered with the Customer Information letter. If you have any questions, contact the Service Manager- Regulatory Affairs at 925-246-8407.
Distribution: Worldwide distribution:
Product codes and lots: All units of the part number: 5857920

Product code IYE

K993425Class IIPrimusSiemens Medical Solutions USA, Inc. / cleared 1999-11-26

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)