Z-0859-2019 Class II Ongoing
FDA device recall Z-0859-2019 was initiated by Philips North America, LLC on January 9, 2019 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 7.
Recall Details
- Product Type
- Devices
- Report Date
- February 27, 2019
- Initiation Date
- January 9, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7
Product Description
PageWriter TC30 w/ trolley Government Bundle, Product 860354, 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.
Code Information
US41510645 US41510646 US71630792 USN1206382 USN1206383 USN1409879 USO1631023