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U.S. Department of Health and Human Services

Class 2 Device Recall Panorama Patient Monitoring Network

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 Class 2 Device Recall Panorama Patient Monitoring Networksee related information
Date Initiated by FirmApril 10, 2009
Date PostedMay 27, 2009
Recall Status1 Terminated 3 on August 03, 2010
Recall NumberZ-1401-2009
Recall Event ID 51863
510(K)NumberK031760 
Product Classification Physiological Patient Monitor (With Arrhythmia Detection or Alarms) - Product Code MHX
ProductPanorama Patient Monitoring Network with ambulatory telepacks, and software version 8.5.5, 8.5.6, 8.6.1 or 8.7. Datascope Patient Monitoring Intended for use in a fixed location, in the healthcare facility setting, as a central viewing station.
Code Information Software version 8.5.5, 8.5.6, 8.6.1, or 8.7.
Recalling Firm/
Manufacturer		 Mindray DS USA, Inc., dba Datascope Patient Monitoring
800 Macarthur Blvd
Mahwah NJ 07430
For Additional Information ContactKathleen Kramer
201-995-8391
Manufacturer Reason
for Recall		Software Anomaly: Software anomaly can occur when the Panorama is attempting to play an audio file, either a physiological or technical alarm sound, at which time the system software may cause the system to freeze due to an interaction in the alarm system.
FDA Determined
Cause 2		Software design
ActionUrgent Product Field Correction letters, dated March 27, 2009, were sent by certified mail, return requested, and signature required. The letters identified the affected product and the problem. It also stated the adverse effect on patients and that customers' Panorama software will be upgraded to a current software revision. A Datascope Service Representative will contact customers to arrange for the software upgrade of the Panorama(s) in their facility. This will be done at no cost to the customer.
Quantity in Commerce294 sites
DistributionWorldwide Distribution -- USA and Australia.
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 = MHX
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