Company: Mindray DS USA, Inc., dba Datascope Patient Monitoring
Date of Enforcement Report 6/3/2009
Class:ll
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. Recall # Z-1401-2009
REASON
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.
RECALLING FIRM/MANUFACTURER
Mindray DS USA, Inc., dba Datascope Patient Monitoring, Mahwah NJ, by letters, dated March 27, 2009. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
294 affected sites
DISTRIBUTION
Nationwide and Australia
