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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm September 24, 2004
Date Posted October 13, 2004
Recall Status1 Terminated 3 on September 15, 2005
Recall Number Z-0018-05
Recall Event ID 30145
510(K)Number K032338  
Product Classification Electrosurgical Electrode Kit - Product Code NWI
Product Trio Monitor. Cardiac Monitor (including cardiotachometer and rate alarm).
Code Information Serial Number:  MC02017-I3; MC02134-I3; MC02138-I3; MC02148-I3; MC02321-K3; MC02002-I3; MC02005-I3; MC02006-I3; MC02008-I3; MC02020-I3; MC02023-I3; MC02025-I3; MC02027-I3; MC02030-I3; MC02034-I3; MC02043-I3; MC02044-I3; MC02048-I3; MC02052-I3. 
Recalling Firm/
Manufacturer		 Datascope Corp
800 MacArthur Blvd
Mahwah NJ 07430-2001
For Additional Information Contact Susan E. Mandy
201-995-8025
Manufacturer Reason
for Recall		 Software anomaly where the variable heart rates may be displayed inaccurately or intermittent 'dashes' may be displayed when the patient's heart rate is derived from ECG.
FDA Determined
Cause 2		 Other
Action Letter was sent on 9/24/2004 via FedEx to the three customers with proof of delivery required.
Quantity in Commerce 19
Distribution Shipments made to three locations. These are Medstone Internation, Aliso Viejo, CA; Indiana Eye Clinic, Greenwood, IN; and Sumter Urologoly Assoc., Sumter, SC.
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 = NWI and Original Applicant = DATASCOPE CORP.
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