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

FDA device recall Z-2611-2011 · posted 2011-06-22 · Terminated

Recall details

Recalling firm

Spacelabs Healthcare, Llc

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.

Action taken

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.

Root cause

Software design

Status

Terminated

Product code

DQK

Quantity affected

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.

Date initiated

2011-05-24

Date posted

2011-06-22

Date terminated

2011-10-26

Location

Issaquah, WA

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