Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1345-2020 — 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 - 453564067

U.S. FDA — Device Enforcement · United States · 2020-01-13 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1345-2020
Date of alert: 2020-01-13
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Philips North America, LLC
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 453564067151

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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