FDA Medical Device Recalls (openFDA)
Inovise Medical, Inc.: AUDICOR 200 D Inovise Part Number 30047 (console part number 20158).
- Recall number
- Z-0565-06
- Recalling firm
- Inovise Medical, Inc.
- Product
- AUDICOR 200 D Inovise Part Number 30047 (console part number 20158).
- Status
- Terminated
- Initiated
- 2003-01-12
- Posted
- 2006-03-03
- Terminated
- 2006-07-24
- 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
- Lot, serial or model codes
- Serial Numbers: 411005, 411007, 411008, 411010, 411011, 411013, 411014, 411015, 411016, 411017, 411018, 411019, 411020, 411023, 411024, 411025, 411026, 411030, 411031, 411032, 411033, 411047, 411048, 411049, 411051, 411052, 411053, 411054.
- 510(k) numbers
- ["K043074"]
- PMA numbers
- not on file
- Product code
- DPS
- Firm FEI
- 3003264460
- Firm city
- Portland
- Firm state
- OR
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28