PageWriter TC70 w/o trolley Government Bundle — Class II medical device recall Z-0858-2019
Ongoing recall by Philips North America, LLC, reported 2019-02-27, distributed nationwide. Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to m
| Recall number | Z-0858-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips North America, LLC, Andover, MA, United States |
| Recall initiated | 2019-01-09 |
| Classified | 2019-02-21 |
| Reported by FDA | 2019-02-27 |
| Distributed | Nationwide (US) |
| Quantity | 2 |
| Reason classes | device malfunction |
Product
PageWriter TC70 w/o trolley Government Bundle, Product 860353, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients
Reason for recall
Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby users.
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-0858-2019. 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.