ONCOR Impression Plus, camera imaging system, Part Number: 5857912, Product is manufactured and distributed by SIEMENS M
FDA device recall Z-2644-2011 · posted 2011-06-23 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc - Radiation Oncology
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- IYE
- Distribution
- Worldwide distribution:
- Date initiated
- 2010-11-04
- Date posted
- 2011-06-23
- Date terminated
- 2011-11-14
- Location
- Concord, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PRIMUS (K993425) | Siemens Medical Solutions USA, Inc. | 1999-11-26 |