A Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute,
FDA device recall Z-1349-2016 · posted 2016-04-07 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- To inform users about the possible incorrect values for Distance Measurements when using certain modalities in combination with syngo Imaging.
- Action taken
- Siemens mailed a Customer Advisory Notice to their customers instructing them to check their modalities for the usage of the mentioned DICOM attributes with different values. They recommended upgrading the workplace(s) to syngo Imaging Studio version VB36D if they have such modalities and it cannot be ensured by the modality provider that only one attribute is filled or both attributes are filled with the same value. Customers were asked to contact their local service organization to clarify the compatibility of their syngo Imaging server version with workplace version VB36D.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 49 imaging systems
- Distribution
- US (nationwide) including the states of AL, CA, CO, CT, FL, IA, IN, KS, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OK, OR, PA, TN, TX, and WI.
- Date initiated
- 2016-01-18
- Date posted
- 2016-04-07
- Date terminated
- 2017-08-03
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNGO IMAGING (VERSION V31) (K081734) | Siemens AG Medical Solutions | 2008-07-03 |
| SYNGO IMAGING (VERSION V30) (K071114) | Siemens AG Medical Solutions | 2007-05-22 |