Philips DigiTrak XT Holter Recorder Software version number B — Class II medical device recall Z-1345-2020
Terminated recall by Philips North America, LLC, reported 2020-03-04, distributed nationwide. if an AAA battery is inserted in the recorder and a user attempts to start it, or if the recorder is inserted
| Recall number | Z-1345-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips North America, LLC, Andover, MA, United States |
| Recall initiated | 2020-01-13 |
| Classified | 2020-02-21 |
| Reported by FDA | 2020-03-04 |
| Terminated | 2023-06-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AF, AR, AT, AU, AW, BD, BE, BG, BM, CA, CH, CN, CW, CY, CZ, DE, DZ, EG, ES, FR, GB, GH, GR, GT, HK, HR, HU, ID, IE, IL, IN, IQ, IR, IS, IT, JO, JP, KE, KR, KW, LB, LK, LU, LV, MT, MX, MY, NG, NI, NL, NO, NP, NZ, OM, PA, PE, PH, PK, PL, PT, QA, RO, RS, SA, SE, SG, SI, SK, TH, TR, TT, TW, VE, VN, ZA |
| Quantity | 44,442 units |
| UPC / GTIN / UDI-DI | 00453564067161 |
| Model numbers | 860322 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1345-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.