FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc - Radiation Oncology: MEV ATRON M2/PRIMUS MID-ENERGY, camera imaging system, Part Number: 1940035; 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.
- Recall number
- Z-2640-2011
- Recalling firm
- Siemens Medical Solutions USA, Inc - Radiation Oncology
- Product
- MEV ATRON M2/PRIMUS MID-ENERGY, camera imaging system, Part Number: 1940035; 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.
- Status
- Terminated
- Initiated
- 2010-11-04
- Posted
- 2011-06-23
- Terminated
- 2011-11-14
- Reason
- 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.
- 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.
- Quantity
- not on file
- Distribution
- Worldwide distribution:
- Lot, serial or model codes
- All units of the part number: 1940035
- 510(k) numbers
- ["K993425"]
- PMA numbers
- not on file
- Product code
- IYE
- Firm FEI
- 2937457
- Firm city
- Concord
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28