Recall Z-0565-06 ยท DPS Electrocardiograph
Inovise Medical, Inc.
AUDICOR 200 D Inovise Part Number 30047 (console part number 20158).
| Date | Mar 3, 2006 (initiated Jan 12, 2003) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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. |
| Quantity | 28 units |
| Distribution | Product distributed to three EMS/Fire Departments located in Florida and Washington |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043074 | LIBERTY SYSTEM Inovise Medical, Inc., Feb 22, 2005 |