Company:Spacelabs Healthcare, LLC
Date of Enforcement Report 8/3/11
Class ll:

PRODUCT
Pathfinder Holter Analyzer is a Programmable Diagnostic Computer. The brochure is labeled in part: “***Pathfinder Holter Analyzer. The Reynolds Pathfinder 700 Holter Analyzer is intended to be used to analyze magnetic tapes of ambulatory electrocardiograms made on compatible Holter Recorders. The system will detect various arrhythmias and will measure ST elevation or depression. The system acts in both a automatic mode (tape analyzed without operator intervention) and in an interactive mode; (operator can intervene and affect analysis). Recall # Z-2611-2011

REASON
A potential hazard associated with the use of Spacelabs Healthcare Pathfinder Holter Analyzer software. The second 24 hours of a 48 hours EVO recording will not be analyzed.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Spacelabs Healthcare, LLC, by letter dated June 3, 2011.
Manufacturer: Del Mar Reynolds Medical, Ltd., Hertford, United Kingdom. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
58 units (5 units in US and 53 internationally)

DISTRIBUTION
Nationwide and Internationally