Symbia-E, Model 10275879
by Siemens Medical Solutions USA, Inc.
510(k) K072567
Symbia-E, Model 10275879 is a Class II device made by Siemens Medical Solutions USA, Inc., cleared under FDA 510(k) K072567 on 30 Oct 2007, active as of 22 Oct 2026. 2 FDA recalls are linked to it.
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK072567 | Date30 Oct 2007 | StatusActive |
Official records
- FDA 510(k) database K072567
Recalls
-
- Terminated Z-1686-2012
Siemens has identified a potential patient safety issue for e.cam and Symbia E camera systems that have had the radial drive motor assembly replaced during a Service action. There is a remote chance that during the motor replacement the radial drive gear may have been replaced incorrectly. If the gear is installed incorrectly the mechanical brake may not engage creating a patient hazard if the sys
-
- Terminated Z-1296-2015
Radial motor drives replaced during a customer service action were incorrectly assembled backwards.
Timeline
- Cleared FDA 510(k) K072567
- Recall initiated FDA recalls Z-1296-2015
- Recall initiated FDA recalls Z-1686-2012
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KPS
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1200
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
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