Recall Z-0333-2022— Northgate Technologies, Inc.

Name: FDA recall Z-0333-2022
Creator: U.S. Food and Drug Administration
Published: 2021-10-25

Class II · Ongoing

Class II FDA medical device recall by Northgate Technologies, Inc., initiated 2021-10-25. It names one FDA 510(k) clearance: K130368. Product: Boston Scientific AUTOLITH TOUCH Bipolar Electrohydraulic Lithotripter, REF M005466800. The device is designed to be used with Northgate Technologies Inc. bipolar disposable EHL probes for the fragmentation of calculi.. Reason: The languages for Russian, Romanian, Slovak, and Czech have the power settings for high and low switched in the device..

Recalling firm: Northgate Technologies, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2021-10-25
Firm location: Elgin, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K130368 — AUTOLITH TOUCH; URO TOUCHNorthgate Technologies, Inc.·cleared 2013-11-15

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

Boston Scientific AUTOLITH TOUCH Bipolar Electrohydraulic Lithotripter, REF M005466800. The device is designed to be used with Northgate Technologies Inc. bipolar disposable EHL probes for the fragmentation of calculi.

Reason for recall

The languages for Russian, Romanian, Slovak, and Czech have the power settings for high and low switched in the device.

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