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U.S. Department of Health and Human Services

Class 2 Device Recall AUDICOR 200 D

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  Class 2 Device Recall AUDICOR 200 D see related information
Date Initiated by Firm January 12, 2003
Date Posted March 03, 2006
Recall Status1 Terminated 3 on July 24, 2006
Recall Number Z-0565-06
Recall Event ID 34472
510(K)Number K043074  
Product Classification Electrocardiograph - Product Code DPS
Product AUDICOR 200 D Inovise Part Number 30047 (console part number 20158).
Code Information 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.
Recalling Firm/
Manufacturer
Inovise Medical, Inc.
10565 Sw Nimbus Ave Ste 100
Portland OR 97223-4311
For Additional Information Contact Steve Hesler
503-431-3800
Manufacturer 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 Determined
Cause 2
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
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DPS and Original Applicant = INOVISE MEDICAL, INC.
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