Recall Z-2793-2016— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-2793-2016
Creator: U.S. Food and Drug Administration
Published: 2016-08-02

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2016-08-02, terminated 2017-03-20. It names one FDA 510(k) clearance: K093612. Product: Syngo Plaza picture archiving and communication system (PAC) (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images.. Reason: Siemens is releasing a Customer Advisory Notice to explain meaning of a suffix o.p. that shows on some DICOM images on area, distance or perimeter values. This suffix stands for on projection and indicates that a shown measurement value may be different from the real value..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2016-08-02
Terminated: 2017-03-20
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K093612 — SYNGO.PLAZASiemens AG Medical Solutions·cleared 2010-03-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Syngo Plaza picture archiving and communication system (PAC) (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images.

Reason for recall

Siemens is releasing a Customer Advisory Notice to explain meaning of a suffix o.p. that shows on some DICOM images on area, distance or perimeter values. This suffix stands for on projection and indicates that a shown measurement value may be different from the real value.

Data sourced from openFDA. This site is unofficial and independent of the FDA.