Agency classClass IIOur severity:High FDA (Devices)·Z-0333-2022·Announced 2021-12-15

Boston Scientific AUTOLITH TOUCH lithotripter power controls reversed in four languages

Boston Scientific AUTOLITH TOUCH Bipolar Electrohydraulic Lithotripter devices distributed to Massachusetts have reversed high and low power settings in Russian, Romanian, Slovak, and Czech language versions. Users selecting a power level may receive the opposite setting.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This device presents a risk of harm through reversed controls without any reported injuries or illnesses. Per the FDA severity rubric, this qualifies as a High (3) rating as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

The Boston Scientific AUTOLITH TOUCH Bipolar Electrohydraulic Lithotripter (model REF M005466800) is subject to recall because the high and low power settings are reversed in Russian, Romanian, Slovak, and Czech language versions. When users select a power setting in these language versions, they may receive the opposite setting from what they intended.

Reversed power settings could affect the proper delivery of treatment during lithotripsy procedures.

Approximately 2,277 devices are affected. The recall applies to units with specific serial number ranges distributed to Massachusetts between February 14, 2017, and October 7, 2021. Only devices operating in the Russian, Romanian, Slovak, or Czech language modes are impacted.

The recalled product

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.
Manufacturer: Northgate Technologies, Inc.
Category: Medical Device — Lithotripter
Hazard: reversed-controls
mis-labeling
Affected units: 2,277

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

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

Distribution

Distributed in 1 state:

Same manufacturer · Northgate Technologies, Inc.

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Same hazard · reversed controls