Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1345-2020·Announced 2020-03-04

Philips DigiTrak XT Holter Recorder Software Recall for Malfunction

Philips is recalling DigiTrak XT Holter Recorders because a software defect causes the device to fail when an AAA battery is present.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard is a functional failure (Error 602) that prevents the device from operating for new studies, but the source text does not report any injuries, illnesses, or deaths.

Plain-English summary

Philips North America, LLC is recalling 44,442 units of the DigiTrak XT Holter Recorder, Model Number 860322. The recall affects software versions B.1 and C.2. The devices are distributed in the United States and numerous foreign countries.

The recall is due to a software defect that causes the recorder to display "Error: 602" and fail to function for a new patient study if an AAA battery is inserted and the user attempts to start the device, or if the recorder is inserted in the docking station. This malfunction prevents the device from performing its intended function for new patient studies.

All Philips 860322 DigiTrak XT Holter Recorders manufactured or distributed before December 31, 2019, are affected, regardless of serial number, ship date, or date of manufacture. Users should contact Philips North America, LLC for instructions on how to resolve the issue.

The recalled product

Product: Philips DigiTrak XT Holter Recorder Software version number B.1 and C.2. The DigiTrak XT Recorder is available in four different configurations. Service tag numbers for these configurations are as follows: - 453564067151 24-Hour Configuration - 453564067161 48-Hour…
Manufacturer: Philips North America, LLC
Category: Medical Device — Cardiac Monitoring
Hazard: software-defect
device-malfunction
Affected units: 44,442

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (7)

All Philips 860322 DigiTrak XT Holter Recorder
manufactured or distributed before December 31
2019
are affected
regardless of serial number
ship date
and date of manufacture.

Distribution

Distributed nationwide across the United States.

Same manufacturer · Philips North America, LLC

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