FDA recall Z-0333-2022

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 for recall

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

Distribution

US Distribution to state of MA.

Key facts

Status

Ongoing

Initiation date

2021-10-25

Report date

2021-12-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Elgin, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0333-2022