Syngo Imaging VB36D_HF02. Radiological image processing system.
FDA device recall Z-0319-2016 · posted 2015-11-20 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- To provide supplementary information regarding the release of the syngo Imaging Software Version VB36D_HF02. The software provides improvements for all syngo Imaging installations running on the software Version VB36D.
- Action taken
- Siemens sent an Customer Information Letter dated October 28, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. If the device has been sold and therefore no longer in your possession, please forward this notice to the new owner. We would also request that you inform us of the identity of the device's new owner where possible. Please observe this safety notice and comply with the corresponding measure until the update has been fully completed. For further questions, please call: (610) 219-6300.
- Root cause
- Software change control
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 3
- Distribution
- US Distribution to the states of : NC, NE and OH.
- Date initiated
- 2015-10-28
- Date posted
- 2015-11-20
- Date terminated
- 2016-10-06
- 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 |