# FDA recall Z-1345-2020

> **Philips North  America, LLC** · Class II · device recall initiated 2020-01-13.

## 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 Configuration  - 453564067171   96-Hour Configuration  - 453564067181   7-Day Configuration    Model Number: 860322

## Reason for recall

if an AAA battery is inserted in the recorder and  a user attempts to start it, or if the recorder is inserted in the docking station, the recorder will display   Error: 602  and fail to function for a new patient study.

## Distribution

US Nationwide  Foreign:  Afghanistan  Albania  Algeria  Argentina  Armenia  Aruba  Australia  Austria  Azerbaijan  Bangladesh  Belarus  Belgium  Bermuda  Bulgaria  Burkina Faso  Canada  China  C¿te D'Ivoire  Croatia  Curacao  Cyprus  Czech Republic  Egypt  France  Germany  Ghana  Gibraltar  Greece  Guatemala  Hong Kong  Hungary  Iceland  India  Indonesia  Iran  Iraq  Ireland  Israel  Italy  Japan  Jordan  Kenya  Korea, Republic of  Kosovo  Kuwait  Latvia  Lebanon  Libya  Luxembourg  Macao  Macedonia  Malaysia  Maldives  Mali  Malta  Mauritius  Mexico  Mongolia  Myanmar  Nepal  Netherlands  Netherlands Antilles  New Zealand  Nicaragua  Nigeria  Norway  Oman  Pakistan  Palestine, State of  Panama  Peru  Philippines  Poland  Portugal  Puerto Rico  Qatar  Romania  Russian Federation  Rwanda  Saudi Arabia  Serbia  Singapore  Slovakia  Slovenia  South Africa  Spain  Sri Lanka  Suriname  Sweden  Switzerland  Taiwan  Thailand  Trinidad and Tobago  Turkey  Uganda  United Arab Emirates  United K

## Key facts

- **Recall number:** Z-1345-2020
- **Recalling firm:** Philips North  America, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-01-13
- **Report date:** 2020-03-04
- **Termination date:** 2023-06-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Andover, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1345-2020

## Citation

> AI Analytics. FDA recall Z-1345-2020. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1345-2020. Source: US FDA. Licensed CC0.

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