Syngo.plaza, Picture Archiving and Communications System (PACS) Syngo.plaza is a Picture Archiving and Communication Sys
FDA device recall Z-1533-2017 · posted 2017-03-10 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Software updates
- Action taken
- Siemens mailed a notification letter dated February 21, 2017 to affected customers to inform them of the software updates that were now available to address several issues. Customers were advised to follow the instructions in the notice and where necessary promptly notify and instruct all their staff at their organization who have to be aware of the problem. Customers were also instructed to forward the information to new owners where possible. For questions regarding this recall call 610-219-4834.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 13 systems
- Distribution
- Nationwide Distribution to MO,TX, FL, MA, WI, PA, IN, and CA
- Date initiated
- 2017-02-20
- Date posted
- 2017-03-10
- Date terminated
- 2017-08-07
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNGO.PLAZA (K093612) | Siemens AG Medical Solutions | 2010-03-04 |