Atlas FDA

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

Monitor recalls programmatically

Recalls and clearances share one API, with change alerts when new recalls post.

Related 510(k) clearances

RecordFirmDate
SYNGO.PLAZA (K093612)Siemens AG Medical Solutions2010-03-04