Spacelabs Healthcare, Llc: 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).

Recall number

Z-2611-2011

Recalling firm

Spacelabs Healthcare, Llc

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).

Status

Terminated

Initiated

2011-05-24

Posted

2011-06-22

Terminated

2011-10-26

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.

Root cause

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

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.

Lot, serial or model codes

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.

510(k) numbers

["K951902"]

PMA numbers

not on file

Product code

DQK

Firm FEI

3010157426

Firm city

Issaquah

Firm state

WA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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