FDA Device recall Z-0856-2019
PageWriter TC20, Product 860332, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric…
- FDA Device
- Class II
- ongoing
- Published 2019-02-27
On 2019-02-27 the FDA classified a Class II recall of PageWriter TC20, Product 860332, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric… 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-0856-2019 |
| 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 TC20, Product 860332, Software revisions up to and including A.07.05.22 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 | CN11201318 CN11201319 CN11201320 CN11201321 CN11201322 CN11201323 CN11201324 CN11201325 CN11201326 CN11201327…CN11201318 CN11201319 CN11201320 CN11201321 CN11201322 CN11201323 CN11201324 CN11201325 CN11201326 CN11201327 CN11201328 CN11201329 CN11201330 CN11201331 CN11201332 CN11201333 CN11201334 CN11201335 CN11201336 CN11201337 CN11201338 CN11201339 CN11201340 CN11201341 CN11201342 CN11201343 CN11201344 CN11201345 CN11201346 CN11201347 CN11201348 CN11201349 CN11201350 CN11201351 CN11201352 CN11201353 CN11201354 CN11201355 CN11201356 CN11201357 CN11201358 CN11201359 CN11201360 CN11201361 CN11201362 CN11201363 CN11201364 CN11201365 CN11201366 CN11201371 CN11201372 CN11201373 CN11201374 CN11201375 CN11201376 CN11201377 CN11201378 CN11201379 CN11201380 CN11201381 CN11201382 CN11201383 CN11201384 CN11201385 CN11201386 CN11201387 CN11201388 CN11201389 CN11201390 CN11201391 CN11201392 CN11201393 CN11201394 CN11302185 CN11302186 CN11302187 CN11302188 CN11302190 CN11302191 CN11302192 CN11302193 CN11302194 CN11302195 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-0856-2019%22
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