Northgate Technologies, Inc.: Boston Scientific AUTOLITH TOUCH Bipolar Electrohydraulic Lithotripter, REF M005466800. The device is designed to be used with Northgate Technologies Inc. bipolar disposa

Is my product affected?

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.

• UPC 00817183020493

Check against the official notice below — it lists the full affected range.

What happened

Boston Scientific's AUTOLITH TOUCH Bipolar Electrohydraulic Lithotripter (REF M005466800) has been recalled due to a labeling error affecting certain language versions of the device. In Russian, Romanian, Slovak, and Czech language versions, the power settings for high and low are switched, which could lead to incorrect power selection during use. Approximately 2,277 devices were distributed in Massachusetts between February 14, 2017, and October 7, 2021, across multiple serial number ranges.

The recall affects devices with base serial numbers within specific ranges distributed during the noted timeframe. The source document does not specify a remedy or corrective action that affected consumers should take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

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. Quantity: 2,277 devices Lot/code info: All serial number revisions for the following bracketed base serial numbers distributed between 2/14/2017 and 10/7/2021: 21578LAA to 21627LAA 21628BBA to 21662BBA 21667CBA to 21689CBA; 21691CBA to 21697CBA; 21699CBA to 21716CBA 21690CBA, 21698CBA, 21721DBA to 21732DBA; 21734DBA to 21747DBA; 21749DBA to 21756DBA; 21758DBA to 21763DBA; 21765DBA to 21770DBA 21733DBA, 21748DBA, 21757DBA, 21764DBA, 21771EBA to 21781EBA; 21783EBA to 21787EBA; 21789EBA, 21790EBA, 21792EBA to 21800EBA; 21804EBA to 21820EBA 21782EBA, 21788EBA, 21791EBA, 21801EBA to 21803EBA; 21821FBA to 21874FBA 21883HBB to 21942HBB 21954IBB to 22025IBB 22026IBB to 22073IBB 22074IBB to 22130KBB; 22133KBB 22131KBB 22134LBB to 22157LBB 22158ACB to 22229ACB 22230ACB to 22249ACB 22250BCB to 22321BCB 22322CCB to 22393CCB 22394CCB to 22441CCB 22453ECB to 22476ECB 22477FCB to 22488FCB 22489GCB to 22500GCB 22511HCB to 22534HCB 22535ICB to 22558ICB 22559JCB to 22564JCB; 22570JCB to 22575JCB 22566JCB to 22569JCB; 22576JCB, 22577JCB, 22579JCB, 22581JCB to 22585JCB 22565JCB, 22578JCB, 22580JCB, 22586JCB to 22588JCB; 22590JCB to 22593JCB; 22595JCB, 22598JCB 22597JCB, 22600JCB to 22603JCB; 22607JCB to 22609JCB; 22611JCB, 22614JCB, 22615JCB, 22623JCB 22589JCB, 22594JCB, 22596JCB, 22599JCB, 22604JCB, 22606JCB, 22610JCB, 22612JCB, 22613JCB, 22616JCB to 22618JCB 22605JCB, 22619JCB to 22622JCB; 22624JCB to 22630JCB 22637KCB, 22638KCB, 22640KCB to 22666KCB; 22669KCB, 22671KCB to 22637KCB; 22677KCB, 22678KCB, 22680KCB 22636KCB, 22639KCB,

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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