PlainRecalls
FDA Devices Moderate Class II Terminated

Syngo.plaza, Picture archiving and communication system (PACS), Model Numbers - 10863171, 10863172, 10863173,

Reported: July 6, 2016 Initiated: May 9, 2016 #Z-2088-2016

Product Description

Syngo.plaza, Picture archiving and communication system (PACS), Model Numbers - 10863171, 10863172, 10863173,

Reason for Recall

Software error in previous software versions in which two references for the same image may exist in the database.

Details

Units Affected
74 systems
Distribution
US Distribution to the states of : AL, CA, CT, FL, IN, KS, LA, MA, MD, MI, MN, MO, MS, NE, NY, OH, OR, PA, TX, WI
Location
Malvern, PA

Frequently Asked Questions

What product was recalled?
Syngo.plaza, Picture archiving and communication system (PACS), Model Numbers - 10863171, 10863172, 10863173,. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 74 systems.
Why was this product recalled?
Software error in previous software versions in which two references for the same image may exist in the database.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 6, 2016. Severity: Moderate. Recall number: Z-2088-2016.