The Siemens Symbia T series is intended for use by appropriately trained health care professionals to aid in detecting,
FDA device recall Z-0912-2015 · posted 2015-01-06 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Reason for recall
- Siemens Medical Solutions USA, Inc. has received reports of unintended radial motion of the detectors. This unintended motion, should it occur, may cause the patient compression related injuries.
- Action taken
- Siemens sent Customer Safety Advisory Notice letters to all customers of record. The letters instructed customers to: 1) continue to use their system(s); 2) place the safety advisory in the system's instructions for use; and, 3) to anticipate that their local service engineer will contact them to perform an inspection and schedule any necessary repairs by December 2014. Customers were also instructed to share the letter with their support staff and, if the equipment was sold or transferred, to forward the safety notice to the new owner of the equipment. Customers with questions can contact their local service representative or Siemens Medical Solutions at 800-888-7436.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- KPS
- Quantity affected
- 1330 systems
- Distribution
- Worldwide Distribution - USA (naitonwide) and Internationally to Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Costa Rica, Croatia, Czech Repu
- Date initiated
- 2014-08-12
- Date posted
- 2015-01-06
- Date terminated
- 2016-12-23
- Location
- Hoffman Estates, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYMBIA (K131634) | Siemens Medical Solutions USA, Inc. | 2013-08-16 |