Recalls / —
—#139480
Product
Syngo.plaza; picture archiving and communications system Product Usage: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo.plaza also supports storage and archiving of DICOM Structured reports. In a comprehensive imaging syngo.plaza integrates Hospital/Radiology Information Systems (HIS/RIS) to enable customer specific workflows. Syngo.plaza optionally uses a variety of advanced postprocessing applications.
- 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 of device 10592457 with serial numbers: Serial 100544 100499 100600 100571 100263 200308 200309 200310 200311 200312 200313 200314 200315 200316 200317 200318 200319 200320 200321 200322 200323 200324 100146 200277 100177 100138 100174 100491 100492 100596 100198 100181 200251 200252 100301 100302 100539
Why it was recalled
Potential issue leading to data loss and patient data mix-up
Root cause (FDA determination)
Software design
Action the firm took
Siemens sent a Customer Information letter, dated July 6, 2015, to customers The letter identified the affected product, problem and action to be taken. The letter informed cusotmers about the Hotfix software update that was being released.
Recalling firm
- Firm
- Siemens Medical Solutions USA, Inc
- Address
- 40 Liberty Blvd, Mail Code: 65-1A, Malvern, Pennsylvania 19355-1418
Distribution
- Distribution pattern
- US Nationwide Distribution - in the states of CA, OR, FL, MO, NY, WA, MD, MA, NY, WI, KS, MN and PA.
Timeline
- Recall initiated
- 2015-07-06
- Posted by FDA
- 2015-09-02
- Terminated
- 2017-01-06
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #139480. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.