United StatesThe CUSA Clarity C7000 Console (ultrasonic surgical aspirator system), Model C7000, Software Version 2.1.1.909, UDI 10381780126232 (specific serial numbers listed) distributed worldwide including the United States (MI and NY) and multiple countries in Europe, Asia and elsewhere is affected. It was recalled because a software issue can render the touch screen unresponsive.
What's being recalled
CUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical aspirator system.
Recalling firm: Integra LifeSciences Corp. (NeuroSciences), Princeton, NJ, United States.
How to identify it
Model: C7000; UDI: 10381780126232; Serial Numbers: CHA1902101IE, CHA2001301IE, CHA2001401IE, CHA2002301IE, CHA2202301IE, CHA2305101IE, CHA2305401IE, CHA2307001IE, CHA2402201IE, CHB1711001IE, CHB1723601IE, CHB2000801IE, CHB2100901IE, CHB2301401IE, CHB2500101IE, CHC1800601IE, CHC1902601IE, CHC1902701IE, CHC2001201IE, CHD1705801IE, CHD1707101IE, CHD1801001IE, CHD1801101IE, CHD1902501IE , CHE1707201IE, CHE1707301IE, CHE2203301IE, CHE2204001IE, CHE2301001IE , CHE2305001IE, CHE2502901IE, CHE2503101IE, CHE2503201IE, CHE2503401IE, CHE2503701IE, CHF1701401IE, CHF1702701IE, CHF2100701IE, CHF2303701IE, CHF2305401IE, CHG1700101IE, CHG1700801IE, CHG1902401IE, CHG2000201IE, CHG2000301IE, CHG2204101IE, CHG2402301IE, CHG2502801IE, CHG2506001IE, CHH1802901IE, CHH2402801IE, CHH2500601IE, CHJ2001101IE, CHJ2001301IE , CHJ2301201IE, CHJ2304601IE, CHK1700801IE, CHK1702301IE, CHK1703001IE, CHK2402601IE, CHK2403401IE, CHK2404101IE, CHL1701701IE, CHL1900201IE, CHL2102901IE , CHL2103001IE, CHL2301301IE, CHL2302001IE, CHL2302101IE, CHL2403301IE, CHM1901901IE, CHM2100101IE, CHM2101601IE, CHM2200201IE, CHM2200301IE, CHM2200501IE, CHM2300701IE, CHM2402101IE.
The hazard
Software issue that renders the touch screen unresponsive.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Worldwide - US Nationwide distribution in the states of MI & NY. The countries of Belgium, China, Czechia, Dubai, Finland, France, Germany, Italy, Japan, Luxembourg, Netherlands. Poland, Spain, Switzerland, Tunisia & United Kingdom.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)