Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall AUDICOR 200 D

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall AUDICOR 200 Dsee related information
Date Initiated by FirmJanuary 12, 2003
Date PostedMarch 03, 2006
Recall Status1 Terminated 3 on July 24, 2006
Recall NumberZ-0565-06
Recall Event ID 34472
510(K)NumberK043074 
Product Classification Electrocardiograph - Product Code DPS
ProductAUDICOR 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 ContactSteve 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
ActionOn 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 Commerce28 units
DistributionProduct distributed to three EMS/Fire Departments located in Florida and Washington
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DPS
-
-