PRIMUS HI, camera imaging system, Part Number: 4504200; 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.
FDA Recall Z-2641-2011 · Posted 2011-06-23
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Recalling FirmSiemens Medical Solutions USA, Inc - Radiation Oncology
Recall StatusTerminated
Product CodeIYE
Date Initiated2010-11-04
Date Terminated2011-11-14
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.
Firm 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.
Root Cause
Other
Distribution Pattern
Worldwide distribution:
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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