Recall Z-0265-2016— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-0265-2016
Creator: U.S. Food and Drug Administration
Published: 2015-09-24

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2015-09-24, terminated 2016-12-05. It names one FDA 510(k) clearance: K070799. Product: MODULARIS VARIOSTAR; Lithotripter device designed to treat urolithiasis.. Reason: Display freeze of MODULARIS hand control results in information not being updated on the display. Current treatment data is not shown to the user..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2015-09-24
Terminated: 2016-12-05
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K070799 — MODULARIS VARIOSTARSiemens Medical Solutions USA, Inc.·cleared 2007-11-01

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

MODULARIS VARIOSTAR; Lithotripter device designed to treat urolithiasis.

Reason for recall

Display freeze of MODULARIS hand control results in information not being updated on the display. Current treatment data is not shown to the user.

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