FDA Device recall Z-0855-2019
PageWriter TC30, Product 860306, 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 TC30, Product 860306, 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-0855-2019 |
| 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 TC30, Product 860306, 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 | CN11102185 CN11102186 CN11102187 CN11102188 CN11102189 CN11102190 CN11102223 CN11102224 CN11102287 CN11204687…CN11102185 CN11102186 CN11102187 CN11102188 CN11102189 CN11102190 CN11102223 CN11102224 CN11102287 CN11204687 CN11204688 CN11204689 CN11204690 CN11204691 CN11204692 CN11204698 CN11204699 CN11204700 CN11204701 CN11204702 CN11204703 CN11204704 CN11204705 CN11204706 CN11204707 CN11204708 CN11204709 CN11204710 CN11204711 CN11204712 CN11204713 CN11204714 CN11204715 CN11204758 CN11204759 CN11204760 CN11204761 CN11204762 CN11204763 CN11204764 CN11204765 CN11204766 CN11204767 CN11204768 CN11204769 CN11204770 CN11204771 CN11204772 CN11204773 CN11204774 CN11204775 CN11204776 CN11204777 CN11204778 CN11204779 CN11204780 CN11204820 CN11306743 CN11306744 CN11306745 CN11306746 CN11306763 CN11306764 CN11306765 CN11306766 CN11306767 CN11306768 CN11306829 CN11306830 CN11306831 CN11306832 CN11306833 CN11306834 CN11510041 CN11510042 CN11510043 CN11510044 CN11510045 CN11510046 CN11510047 CN11510048 CN11510049 CN11510050 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-0855-2019%22
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