AUDICOR 200 D Inovise Part Number 30047 (console part number 20158).
FDA device recall Z-0565-06 · posted 2006-03-03 · Terminated
Recall details
- Recalling firm
- Inovise Medical, Inc.
- Reason for recall
- Use of the AUDICOR 200 D in-line with a defibrillator/monitor resulted in interruption of pacing therapy to a patient when the AUDICOR 200 D stopped working due to low battery power.
- Action taken
- On January 12, 2006, 2 of 3 customers were notified by telephone, with follow-up email. All three customers were visited by the firm on January 16-17, 2006. Customers were instucted to not use the device in-line with a defibrillator/monitor.
- Root cause
- Other
- Status
- Terminated
- Product code
- DPS
- Quantity affected
- 28 units
- Distribution
- Product distributed to three EMS/Fire Departments located in Florida and Washington
- Date initiated
- 2003-01-12
- Date posted
- 2006-03-03
- Date terminated
- 2006-07-24
- Location
- Portland, OR
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LIBERTY SYSTEM (K043074) | Inovise Medical, Inc. | 2005-02-22 |