Z-2611-2011

Pathfinder Holter Analyzer is a Programmable Diagnostic Computer. The brochure is labeled in part...

Name: Z-2611-2011 Pathfinder Holter Analyzer is a Programmable Diagnostic Computer. The brochure is labeled in part...
Creator: Spacelabs Healthcare, Llc
Published: 2011-05-24
License: https://open.fda.gov/license/

GE Healthcare / initiated 2011-05-24 / Terminated / root cause: software

FDA source

Spacelabs Healthcare, Llc began a recall of Pathfinder Holter Analyzer is a Programmable Diagnostic Computer. The brochure is labeled in part: "***Pathfinder Holter Analyzer ***Spacelabs Healthcare... on 2011-05-24. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2611-2011
Status: Terminated
Initiated: 2011-05-24
Posted: 2011-06-22
Terminated: 2011-10-26
Recalling firm: GE Healthcare
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).
Product code: DQK Computer, Diagnostic, Programmable
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.
Root cause tag: software
FDA 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 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.
Product codes and lots: 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.

Product code DQK

K951902Class IIPathfinder 700 Holter AnalyzerReynolds Medical , Ltd. / cleared 1996-07-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)