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LithoClast

E.M.S. Electro Medical Systems S.A. · Model FR-094 · UDI-DI 07613353000356

FFK Prescription

510(k) clearances

438

Adverse events (9 deaths)

Recalls

Facilities

Description

Pneumatic Handpiece Kit

Recalls

Date	Firm	Reason
2022-04-13	Northgate Technologies, Inc.	Product labeled incorrectly.
2021-10-25	Northgate Technologies, Inc.	The languages for Russian, Romanian, Slovak, and Czech have the power settings for high and low switched in the device.
2020-03-10	Northgate Technologies, Inc.	As part of an investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.
2020-03-10	Northgate Technologies, Inc.	Investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.
2020-03-10	Northgate Technologies, Inc.	Investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.
2018-01-31	Cook Inc.	The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use.
2018-01-31	Cook Inc.	The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use.
2018-01-31	Cook Inc.	The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use.
2018-01-31	Cook Inc.	The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use.
2018-01-31	Cook Inc.	The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.