Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Viasys Healthcare NicoletOne ICU Monitor, Modular Neurodiagnostic System (containing Axiomtek Panel PC computer system), released and installed between December 2004 and March 2007 (Axiomtek Panel PC Model Number: 2147-671) VIASYS NeuroCare Part Numbers: 842-673800, 842-673900, 982A0421 and 982A0422. Manufactured, designed, developed and marketed by VIASYS NeuroCare Inc., Madison, WI 53711

FDA Recall Z-0126-2008 · Posted 2008-01-03

Recalling FirmNicolet Biomedical Div of Viasys Healthcare
Recall StatusTerminated
Product CodeGWQ
Date Initiated2007-09-11
Date Terminated2011-12-10
Product Quantity33

Reason for Recall

Display lock-up: VIASYS Healthcare NicoletOne ICU Monitor freezes up during operation when using the digital video option.

Firm Action

Certified direct mail delivery of URGENT MEDICAL DEVICE FIELD CORRECTION (RECALL) were made to consignees on 9/11/07 by Nicolet Biomedical Div of Viasys Healthcare. The letter describes the product and problem. VIASYS requests that customers cease use of the video option of the device until the monitor can be replaced by VIASYS authorized personnel. Letter also requests consignees to fax or mail back the response form.

Root Cause

Component design/selection

Distribution Pattern

Worldwide Dsitribution - USA, Germany, Netherlands, Kuwait, Japan, Ireland, and China.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K021185NERVUS MONITORTaugagreining HF · 2002-07-12

Official Source

View FDA Recall →

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

↑