Company:Spacelabs Healthcare, LLC.
Date of Enforcement Report 6/27/12
Class ll:
PRODUCT
The product is Pathfinder SL, version 1.6.0.3057 software used with the Spacelabs Healthcare Pathfinder SL Holter Analyzer, version 1.6.0. Product Usage: The Holter Analyzer analyzes information collected from ambulatory electrocardiogram recorders worn by patients and used to assist physicians in diagnosis and patient monitoring. In addition, incorrect QTc values are reported after moving the cursor. QTc values are timing events between labeled points of interest in the ECG signal that the physician can mark with the cursor. The software is used to edit a family of events and upon conclusion the software crashes with an error message.
Recall Number Z-1831-2012
REASON
The firm received reports of the Pathfinder LS software crashing after editing a batch of Holter Analyzer records. The software will stop with an error message requiring a restart. In addition, QTc values will not update after moving the marker.
RECALLING FIRM/MANUFACTURER
Spacelabs Healthcare, Llc, Issaquah, WA on 2012-05-11. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
114 devices
DISTRIBUTION
Nationwide and Internationally
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