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Terminated

NicoletOne vEEG System, VIASYS Healthcare, Inc., Madison, Wisconsin 53711.

FDA Recall Z-1256-2010 · Posted 2010-04-07

Recalling FirmCareFusion
Recall StatusTerminated
Product CodeGWQ
Date Initiated2010-03-08
Date Terminated2012-07-05
Product Quantity2,984 US; 3,147 OUS

Reason for Recall

CareFusion NeuroCare is voluntarily implementing a field correction to delete certain NicoletOne software protocols, which users may interpret incorrectly when conducting patient evaluations. This may result in the misinterpretation of the left versus right side of the brain. Users are being provided with instructions for removing these protocols and verifying that the deletion has been prop

Firm Action

Consignees were sent a CareFusion "Urgent Medical Device Correction" letter dated March 3, 2010. The letter described the problem and product involved. The letter included "Action to be taken by Users," "Instructions for deleting protocols," and "Photos-Amplifier label and Headbox insert to be discarded". It also included a "Verification Form" to be completed by recipient. For questions, notify CareFusion-NeuroCare, Attention: Sue Niesen, at (800) 356-0007 ext. 5129, or via email at [email protected]

Root Cause

Software design

Distribution Pattern

All States in the United States including DC. UNITED ARAB EMIRATES, ALBANIA, ARGENTINA, AUSTRIA, AUSTRALIA, AZERBAIJAN, BANGLADESH, BELGIUM, BULGARIA, BAHRAIN, CANADA, SWITZERLAND, CHILE, CHINA, COLOMBIA, COSTA RICA, CZECHOSLOVAKIA, CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, ESTONIA, EGYPT, SPAIN, ETHIOPIA, FINLAND, FRANCE, GREAT BRITAIN, GREECE, GUAM, GERMANY, HONG KONG, HUNGARY, CRO ATIA, INDONESIA, IRELAND, ISRAEL, INDIA, ICELAND, ITALY, JORDAN, JAPAN, KOREA SOUTH, KWAI T, KAZAKHSTAN, LEBANON, LIECHTENSTEIN, LATVIA, MOROCCO, MALDOVA, MACEDONIA, MALTA, MAURITIUS, MEXICO, MALAYSIA, NIGERIA, NETHERLANDS, NORWAY, PANAMA, PERU, PHILIPPINES, PAKISTAN, POLAND, PUERTO RICO, PALESTINIAN TERRITORY, QATAR, ROMANIA, SERBIA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVEN IA, SLOVAK REPUBLIC, THAILAND, TURKEY, TAIWAN, URUGUAY, UKRAINE, VENEZUELA, YEMEN, VI ET NAAM, YUGOSLAVIA, SOUTH AFRICA,

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K991054BRAVO MULTI-MODALITY SYSTEMNicolet Biomedical, Inc. · 1999-11-03

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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