PageWriter TC70 w/trolley Government Bundle, Product 860352, Software revisions up to and includi...
FDA Device Recall #Z-0857-2019 — Class II — January 9, 2019
Recall Summary
| Recall Number | Z-0857-2019 |
| Classification | Class II — Moderate risk |
| Date Initiated | January 9, 2019 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Philips North America, LLC |
| Location | Andover, MA |
| Product Type | Devices |
| Quantity | 57 |
Product Description
PageWriter TC70 w/trolley Government Bundle, Product 860352, 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.
Distribution Pattern
Domestic distribution nationwide. Foreign distribution worldwide.
Lot / Code Information
US21512485 US21512486 US21512487 US21512488 US21512489 US21512490 US31722466 US31722467 US31722468 US31722469 US41513026 US61722772 US61722773 US71621391 US71722865 US71722866 US81208557 US81208558 US81309947 US81411777 US81411819 US81411820 US81621422 US91412024 US91412025 US91412026 US91513515 US91513521 US91513522 US91513585 US91621626 USD1513746 USN1621889 USN1723144 USN1723145 USO1310393 USO1310394 USO1310395 USO1310396 USO1513640 USO1621655 USO1831199 USO1831200 USO1831201 USO1831202 USO1831208 USO1831209 USO1831210 USO1831211 USO1831212 USO1831213 USO1831214 USO1831215 USO1831216 USO1831217 USO1831218 USO1831219
Other Recalls from Philips North America, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0926-2022 | Class II | The IFU for the Autoclavable Temperature Probes... | Feb 7, 2022 |
| Z-1326-2021 | Class II | Philips SureSigns VM4, VM6 and VM8 - Product Us... | Mar 23, 2021 |
| Z-0852-2021 | Class II | Emission Computed Tomography System Image Proce... | Nov 19, 2020 |
| Z-0284-2021 | Class II | Philips Sterilizable Defibrillator Paddles, Swi... | Sep 14, 2020 |
| Z-0285-2021 | Class II | Philips Sterilizable Defibrillator Paddles, Swi... | Sep 14, 2020 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.