Z-0565-06

AUDICOR 200 D Inovise Part Number 30047 (console part number 20158)

Name: Z-0565-06 AUDICOR 200 D Inovise Part Number 30047 (console part number 20158)
Creator: Inovise Medical, Inc.
Published: 2003-01-12
License: https://open.fda.gov/license/

Inovise Medical, Inc. / initiated 2003-01-12 / Terminated

FDA source

Inovise Medical, Inc. began a recall of AUDICOR 200 D Inovise Part Number 30047 (console part number 20158) on 2003-01-12. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0565-06
Status: Terminated
Initiated: 2003-01-12
Posted: 2006-03-03
Terminated: 2006-07-24
Recalling firm: Inovise Medical, Inc.
Product: AUDICOR 200 D Inovise Part Number 30047 (console part number 20158).
Product code: DPS Electrocardiograph
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.
FDA 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 in commerce: 28 units
Distribution: Product distributed to three EMS/Fire Departments located in Florida and Washington
Product codes and lots: 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.

Product code DPS

K043074Class IILiberty SystemInovise Medical, Inc. / cleared 2005-02-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)