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Terminated

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

FDA Recall Z-2088-2016 · Posted 2016-06-29

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeLLZ
Date Initiated2016-05-09
Date Terminated2017-03-20
Product Quantity74 systems

Reason for Recall

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

Firm Action

Siemens sent an Customer Information letter dated May 10, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter with software instruction to customers informing them about an upcoming software VB10B under(SY003/16/P) update change and issue that the new software version will address. For further questions, please call (610) 448-6478.

Root Cause

Software design

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K093612SYNGO.PLAZASiemens AG Medical Solutions · 2010-03-04

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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