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 Panorama Patient Monitoring Network

  • 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 Panorama Patient Monitoring Network see related information
Date Initiated by Firm April 10, 2009
Date Posted May 27, 2009
Recall Status1 Terminated 3 on August 03, 2010
Recall Number Z-1401-2009
Recall Event ID 51863
510(K)Number K031760  
Product Classification Physiological Patient Monitor (With Arrhythmia Detection or Alarms) - Product Code MHX
Product Panorama 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 Contact Kathleen 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
Action Urgent 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 Commerce 294 sites
Distribution Worldwide Distribution -- USA and Australia.
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.
-
-