Viasys Healthcare NicoletOne ICU Monitor, Modular Neurodiagnostic System (containing Axiomtek Panel PC computer system),
FDA device recall Z-0126-2008 · posted 2008-01-03 · Terminated
Recall details
- Recalling firm
- Nicolet Biomedical Div of Viasys Healthcare
- Reason for recall
- Display lock-up: VIASYS Healthcare NicoletOne ICU Monitor freezes up during operation when using the digital video option.
- Action taken
- 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
- Status
- Terminated
- Product code
- GWQ
- Quantity affected
- 33
- Distribution
- Worldwide Dsitribution - USA, Germany, Netherlands, Kuwait, Japan, Ireland, and China.
- Date initiated
- 2007-09-11
- Date posted
- 2008-01-03
- Date terminated
- 2011-12-10
- Location
- Madison, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NERVUS MONITOR (K021185) | Taugagreining HF | 2002-07-12 |