Recalls / —
—#152622
Product
Syngo.plaza, picture archiving and communications system.
- FDA product code
- LLZ — System, Image Processing, Radiological
- Device class
- Class 2
- Medical specialty
- Radiology
- 510(k) numbers
- K093612
- Affected lot / code info
- Model Number: 10863171, 10863172, 10863173 Serial Numbers: 100262 100198 100258 100259 100135 100538 100133 100031 100105 100106 100109 100110 100111 100112 100113 100114 100115 100116 100117 100119 100120 100416 100461 100245 100447 100364 100298 100299 100386 100139 100027 100440 100441 100559 100025 100033 100196 100189 100190 100191 100192 100195 100186 100232 100450 100449 100256 100199 100188 100194 100198 100029 100253 100203 100204 100132 100139 100434 100476 100495 100491 100206
Why it was recalled
Software update for improvements and to resolve several issues
Root cause (FDA determination)
Under Investigation by firm
Action the firm took
Siemens mailed a Customer Letter to affected customers on 01/13/2017 to provide information about the latest software change that is now 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 throughout the United States.
Timeline
- Recall initiated
- 2017-01-11
- Terminated
- 2017-11-16
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #152622. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.