Recalls / —

—#149546

Product

Syngo.plaza VB10A, Picture Archiving and Communication System

FDA product code

LLZ — System, Image Processing, Radiological

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K132532

Affected lot / code info

Serial Numbers: 100262 100198 100258 100259 100538 100133 100213 100214 100031 100484 100362 100416 100461 100457 100447 100139 100027 100559 100440 100441 100025 100084 100186 100189 100190 100191 100192 100195 100196 100033 100232 100449 100450 100199 100256 100228 100425 100029 100253 100203 100204 100132 100434 100491 100495 100206

Why it was recalled

Software upgrade to eliminate several issues

Root cause (FDA determination)

Software design

Action the firm took

Siemens notified customers via mail on 09/07/2016 informing them of the latest syngo.plaza software change that was available to address several issues.

Recalling firm

Firm

Siemens Medical Solutions USA, Inc

Address

40 Liberty Blvd, Malvern, Pennsylvania 19355-1418

Distribution

Distribution pattern

Distributed Nationwide

Timeline

Recall initiated

2016-09-06

Posted by FDA

2016-09-27

Terminated

2017-05-08

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #149546. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.