Class 2 Device Recall

• Date Initiated by Firm: August 19, 2005
• Date Posted: September 21, 2005
• Recall Status: Terminated on June 21, 2006
• Recall Number: Z-1567-05
• Recall Event ID: 33230
• 510(K)Number: K031760
• Product Classification: Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) - Product Code DRT
• Product: Panorama Patient Monitoring Network, Cardiac Arrhythmia Monitor.
• Code Information: Part Number 0040-00-0366-20.
• FEI Number: 2221819
• 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: The software version contains an anomaly which could freeze the unit when the right click button is used on the mouse.
• FDA Determined Cause: Other
• Action: A recall letter was sent to the consignees on 8/19/2005.
• Quantity in Commerce: 115 units
• Distribution: The affected software was distributed to 108 domestic sites and seven international sites. There are no sale of affected Panorama software to the US Govt.
• 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 = DRT