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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 December 07, 2005
Date Posted January 24, 2006
Recall Status1 Terminated 3 on August 01, 2006
Recall Number Z-0437-06
Recall Event ID 34320
510(K)Number K031760  
Product Classification Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) - Product Code MHX
Product Panorama Patient Monitoring Network, Cardiac Arrhythmia Monitor.
Code Information All Panorama Central Station containing software versions 8.1.6 - 8.2
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 that affects the Panorama Telepack where if communications are lost during standby, certain alarms which appear set could be actually off.
FDA Determined
Cause 2		 Other
Action Datascope sent letters to the distributors and end users on 12/7/2005. This communication states that a Datascope Service Representative will conduct and document the corrective action during a visit to the customer.
Quantity in Commerce 110 sites
Distribution The product was distributed to hospitals and clinics nationwide. There is one US Government account, VA Medical Center, Birmingham, AL.
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 = MHX and Original Applicant = DATASCOPE CORP.
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