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Terminated

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.

FDA Recall Z-1831-2012 · Posted 2012-06-20

Recalling FirmSpacelabs Healthcare, Llc
Recall StatusTerminated
Product CodeDQK
Date Initiated2012-05-11
Date Terminated2012-10-22
Product Quantity114

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.

Firm Action

Spacelabs Healthcare, Llc sent a "MEDICAL DEVICE CORRECTION" letter dated May 11, 2012 via mailed, return receipt requested, to US customers. The customer letter (translated as necessary) was emailed to all international subsidiaries and distributors of record. The letter identified the affected product, problem and actions to be taken. Consignees are advised to turn the power off and then on to restore normal functionality. Updated software will be provided upon completion of validation. For questions contact Spacelabs Healthcare at 1-800-522-7025 and select 3 for Technical Support.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution - US (nationwide) including the states of Nevada and Vermont, and the countries of AUSTRALIA, AUSTRIA, CANADA, CYPRUS, GERMANY, ICELAND, ISRAEL, POLAND, ROMANIA, SOUTH AFRICA, SWITZERLAND, THAILAND, TURKEY and UNITED KINGDOM.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K110001SPACELABS PATHFINDER SL HOLTER ANALYZERSpacelabs Healthcare, Ltd. · 2011-06-14

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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