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U.S. Department of Health and Human Services

Class 2 Device Recall Pathfinder Holter Analyzer

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  Class 2 Device Recall Pathfinder Holter Analyzer see related information
Date Initiated by Firm May 24, 2011
Date Posted June 22, 2011
Recall Status1 Terminated 3 on October 26, 2011
Recall Number Z-2611-2011
Recall Event ID 59004
510(K)Number K951902  
Product Classification Computer, diagnostic, programmable - Product Code DQK
Product Pathfinder Holter Analyzer is a Programmable Diagnostic Computer.

The brochure is labeled in part: "***Pathfinder Holter Analyzer ***Spacelabs Healthcare Company Headquarters***5150 220th Ave. SE, Issaquah, WA 98029***PO Box 7018, Issaquah, WA 98027-7018***Telephone: 425-657-7200***In North America: 800-522-7025***www.spacelabshealthcare.com***".

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).
Code Information Serial Numbers: PATH-6020, PATH-6412, PATH-9072, PATH-12569, PATH-33320, PATH-33331, PATH-006005, PATH-006043, PATH-006175, PATH-006302, PATH-006314, PATH-006317, PATH-006319, PATH-006332, PATH-006333, PATH-006350, PATH-006351, PATH-006447, PATH-006448, PATH-006449, PATH-006450, PATH-006486, PATH-006487, PATH-006488, PATH-006489, PATH-006502, PATH-006505, PATH-006506, PATH-006527, PATH-006528, PATH-006531, PATH-006537, PATH-006538, PATH-006542, PATH-006544, PATH-006545, PATH-006572, PATH-006573, PATH-006609, PATH-006610, PATH-006612, PATH-006613, PATH-006630, PATH-006631, PATH-006632, PATH-006662, PATH-006663, PATH-006664, PATH-006665, PATH-006666, PATH-006712, PATH-006735, PATH-006736, PATH-006738, PATH-006831, PATH-006839, PATH-006858, and PATH-006861.
Recalling Firm/
Spacelabs Healthcare, Llc
5150 220th Ave Se
Issaquah WA 98029-6834
For Additional Information Contact Spacelabs Healthcare
425-657-7200 Ext. 5970
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
Software design
Action Spacelabs Healthcare sent a "URGENT-MEDICAL DEVICE CORRECTION" letter dated June 3, 2011 to all customers. The letter describes the product, problem, and the actions to be taken by the customers. Spacelabs Healthcare recommended that until software upgrades can be done, the customers should weigh the benefits versus the risks when deciding whether or not to continue using the product. Spacelabs Healthcare also recommended that customers advise their staff that the second 24 hours of a 48 hour EVO recording would not be analyzed. Field service engineers will be contacting customers to set up a time and date to install the revised version of the Pathfinder software. Spacelabs will upgrade Pathfinder software regardless of whether the consignees are using EVO recorders to ensure this hazard does not happen in the future. Consignees can call Spacelabs Healthcare at 1-800-522-7025 and select 2 for Technical Support, or outside the US, 44 1992 507740 for any questions about this recall.
Quantity in Commerce 58 units total (5 units in US and 53 units internationally)
Distribution Worldwide Distribution--USA (nationwide) including states of CA and NC and countries of Czech Republic, Denmark, Hong Kong, Israel, The Netherlands, and United Kingdom.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DQK and Original Applicant = REYNOLDS MEDICAL LTD.