Viasys Healthcare, Sonora Transcranial Doppler (TCD) System. Model Sonara. Part Number of Units: 982A0470 Sonara Bilater
FDA device recall Z-0999-2009 · posted 2009-04-07 · Terminated
Recall details
- Recalling firm
- Cardinal Health, Inc
- Reason for recall
- Internal testing has identified several several scenarios where unexpected System lockups, shutdowns or system errors would render the Sonara unavailable for use until the Sonara can be restarted. These issues can be corrected by installing the Version 6.0 b045 software updating the Audio Driver and updating to XP Service Pack 3. Additionally, improper wiring could cause the cooling fan to not op
- Action taken
- Consignees were sent a Cardinal Health "Urgent: Medical Device Correction" letter dated January 12, 2009 beginning the week of February 2, 2009 and continuing into week of February 9, 2009. The letter was addressed to customers describing the problems and systems affected and solutions. Cardinal Health requested customers to complete the actions listed in the letter to install the Field Correction and return the completed "Verification Form" via mail, e-mail or fax to Cardinal Health-NeuroCare. Further information can be obtained by calling 1-800-356-0007 ext 2191 or fax to 1-877-244-3805.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- IYN
- Quantity affected
- 64 systems
- Distribution
- Worldwide Distribution -- USA including states of FL, DC, LA, NJ, NY, PA, TN, TX, WI, CA, MO, and LA and countries including THAILAND, SINGAPORE, SERBIA-MONTENEGRO, PORTUGAL, PHILIPPINES, POLAND, NORW
- Date initiated
- 2009-01-06
- Date posted
- 2009-04-07
- Date terminated
- 2012-07-03
- Location
- Madison, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SONARA; SONARA/TEK (K060421) | Viasys Healthcare, Inc. | 2006-11-03 |