| Date Initiated by Firm | December 22, 2015 |
|---|
| Date Posted | February 23, 2016 |
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| Recall Status1 |
Terminated 3 on September 05, 2017 |
| Recall Number | Z-0862-2016 |
|---|
| Recall Event ID |
73041 |
| 510(K)Number | K093612 K132532 |
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| Product Classification |
System, image processing, radiological - Product Code LLZ
|
| Product | Syngo Plaza Picture archiving and communication system.
Software only.
PACS intended to display, process, read, report, communicate, distribute, store and archive digital medical images. Stores and archives within DICOM structured reports. Integrates hospital/radiology information systems. |
|---|
| Code Information |
Device model numbers: 10863171, 10863172, 10863173 |
Recalling Firm/
Manufacturer |
Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
|
| For Additional Information Contact | Anastasia Sokolova
610-448-6478 |
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Manufacturer Reason
for Recall | Siemens is releasing an updated software version to address several software issues including RGB images will show "?" since calculation of HU is not possible; save as option enabled; changes in access for loading studies; breast region is now properly fitted to segment boundary when clicking fit breast to screen. |
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FDA Determined
Cause 2 | Software design |
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| Action | Siemens sent a Voluntary Correction and Removal Action letter dated December 30, 2015. The letter identified the product, the problem, and the action to be taken by the customer. Customers were notified that a software update VB10A_HF01/06 is being released simulataneously to eliminate the issue. Customers with questions were instructed to call 1-888-826-9702. |
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| Quantity in Commerce | 68 |
|---|
| Distribution | Nationwide Distribution including AL
CA
CT
FL
IN
KS
LA
MA
MD
MI
MN
MO
MS
NE
NY
OH
OR
PA
TX
WA
WI |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database | 510(K)s with Product Code = LLZ
510(K)s with Product Code = LLZ
|
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