CT syngo Dual Energy Viewer on the syngo Multimodality Work Place (MMWP) and on the CT workplace, Model number 10094833.
FDA device recall Z-0647-2009 · posted 2009-01-08 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Indicated orientation does not match actual orientation of the patient.
- Action taken
- The recalling firm issued a Customer Safety Advisory dated 10/8/08 to affected customers via Update Instructions CT052/08/S. The letter informs customers of the potential issue and provides instructions to avoid its occurrence. Customers should consider "no saving of calculated Dual Energy data sets from non-supine and mirror-option scans via "Save Sets CT"-button." The firm also highly recommends for customers "to check the correct display of "left", "anterior" and "posterior"markings, e.g. by checking the position of the spine with respect to the posterior marking in the image." The error should be fixed within certain upgrade and installation activities on the affected software.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 374 units
- Distribution
- Nationwide Distribution
- Date initiated
- 2008-11-13
- Date posted
- 2009-01-08
- Date terminated
- 2013-03-19
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNGO MULTIMODALITY WORKPLACE (SYNGO MM WP) (K052775) | Siemens AG Medical Solutions | 2005-10-31 |