FDA Device recall Z-0854-2019
PageWriter TC50, Product 860310, Software revisions up to and including A.07.05.22 used to evaluate the electrocardiogram of adult and pedi…
- FDA Device
- Class II
- ongoing
- Published 2019-02-27
On 2019-02-27 the FDA classified a Class II recall of PageWriter TC50, Product 860310, Software revisions up to and including A.07.05.22 used to evaluate the electrocardiogram of adult and pedi… by Philips North America, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0854-2019 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-01-09 |
| Published | 2019-02-27 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Philips North America |
| Distribution | US |
Product
PageWriter TC50, Product 860310, Software revisions up to and including A.07.05.22 used to evaluate the electrocardiogram of adult and pediatric patients
Reason
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.
Identifiers
| code_info | CN11102314 CN11102315 CN11102316 CN11102317 CN11203436 CN11203443 CN11203444 CN11203453 CN11203454 CN11203455…CN11102314 CN11102315 CN11102316 CN11102317 CN11203436 CN11203443 CN11203444 CN11203453 CN11203454 CN11203455 CN11304748 CN11304749 CN11304762 CN11304772 CN11304773 CN11304802 CN11304803 CN11304805 CN11304806 CN11304809 CN11406020 CN11406033 CN11406034 CN11507236 CN11507237 CN11507238 CN11507259 CN11507260 CN11507261 CN11507262 CN11507263 CN11507264 CN11630099 CN11630100 CN11630101 CN11630102 CN11630103 CN11630104 CN11630105 CN11630106 CN11630107 CN11630108 CN11630109 CN11630110 CN11630111 CN11630112 CN11630113 CN11630114 CN11630122 CN11630123 CN11630124 CN11630125 CN11630126 CN11630128 CN11630129 CN11630130 CN11630131 CN11630132 CN11630133 CN11630134 CN11630135 CN11630136 CN11630138 CN11630139 CN11630140 CN11630141 CN11630142 CN11630143 CN11630144 CN11630145 CN11630146 CN11630147 CN11630148 CN11630149 CN11630150 CN11630151 CN11630154 CN11630155 CN11630156 CN11630157 CN11630158 CN11630159 CN11630160 CN11 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0854-2019%22
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