Recall Z-1831-2012— Spacelabs Healthcare, Llc

Name: FDA recall Z-1831-2012
Creator: U.S. Food and Drug Administration
Published: 2012-05-11

Class II · Terminated

Class II FDA medical device recall by Spacelabs Healthcare, Llc, initiated 2012-05-11, terminated 2012-10-22. It names one FDA 510(k) clearance: K110001. 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.. 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: Spacelabs Healthcare, Llc
Classification: Class II
Status: Terminated
Initiated: 2012-05-11
Terminated: 2012-10-22
Firm location: Issaquah, WA, United States

510(k) clearances named in this recall

1 on FDA's record

K110001 — SPACELABS PATHFINDER SL HOLTER ANALYZERSpacelabs Healthcare, Ltd.·cleared 2011-06-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.