Syngo Dynamics; Kinetdx Picture Archiving and Communications System
FDA device recall Z-1601-2016 · posted 2016-05-04 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Siemens has identified changes in default carry forward workflow using VA10B_HF03 version of Syngo Dynamics. If the template design has measurements inside a carry forward-configured report section, this will result in carrying forward the entire section of the report including data from previous studies. This may result in the physician making analysis based on the old measurements.
- Action taken
- Siemens mailed out a "Customer Advisory Notice" #SY009/16/P to customers informing them of the issue and what to do if it was to occur. Siemens informed customers that they are working on the "carry forward" feature enhancement and is planning to release a software update VA10B_HF06 and they should follow the instructions in the advisory notice until the update is performed.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 84 units
- Distribution
- Nationwide: AZ, CA, IL, IN, MA, MD, MI, MN, NJ, NY, OH, OR, PA, TN, TX, UT, WA, WI
- Date initiated
- 2016-04-14
- Date posted
- 2016-05-04
- Date terminated
- 2017-03-20
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| KINETDX PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM (K023772) | Acuson Corp. | 2002-11-22 |