SOMATOM CT System Sensation Cardiac (+ Straton), Computed Tomography X-Ray System, Model Numbers 75 43 106
FDA device recall Z-0161-05 · posted 2004-11-03 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Calcium Scoring feature on this devices is not closing properly after patient's exams.
- Action taken
- The recalling firm issued a Customer Safety Advisory with Update Instructions, CT036/04/S and CN048.04/2 to their affected customers. The letter informed the customers of the potential issue and provided instructions to avoid the problem while using this feature. A software upgrade is being developed to corect this issue.
- Root cause
- Other
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 47 units
- Distribution
- The product was shipped to medical facilities nationwide and government account in IL.
- Date initiated
- 2004-09-28
- Date posted
- 2004-11-03
- Date terminated
- 2008-09-04
- Location
- Malvern, PA
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