Recall Z-2275-2012— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-2275-2012
Creator: U.S. Food and Drug Administration
Published: 2012-07-18

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2012-07-18, terminated 2014-01-24. It names one FDA 510(k) clearance: K101666. Product: syngo.plaza, Model number 10592457. Intended use: radiological image processing system.. Reason: There is a potential malfunction in which a miscalculation occurs for images with pixel depth values greater that 12 bit in certain functions..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2012-07-18
Terminated: 2014-01-24
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K101666 — SYNGO. PLAZA VA20ASiemens AG Medical Solutions·cleared 2010-08-10

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, Model number 10592457. Intended use: radiological image processing system.

Reason for recall

There is a potential malfunction in which a miscalculation occurs for images with pixel depth values greater that 12 bit in certain functions.

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