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U.S. Department of Health and Human Services

Class 2 Device Recall Spacelabs Healthcare Pathfinder SL Holter Analyzer

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 Class 2 Recall
Spacelabs Healthcare Pathfinder SL Holter Analyzer
see related information
Date Posted June 20, 2012
Recall Status1 Terminated on October 22, 2012
Recall Number Z-1831-2012
Recall Event ID 61913
Premarket Notification
510(K) Number
K110001 
Product Classification Computer, Diagnostic, Programmable - Product Code DQK
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.
Code Information Version 1.6.0.
Recalling Firm/
Manufacturer
Spacelabs Healthcare, Llc
5150 220th Ave Se
Issaquah, Washington 98029-6834
Consumer Instructions Contact the recalling firm for information
Manufacturer 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.
FDA Determined
Cause 2
DESIGN: Software Design
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.
Quantity in Commerce 114
Distribution 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DQK and Original Applicant = SPACELABS HEALTHCARE LTD.
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