Z-0861-2019 Class II Ongoing
FDA device recall Z-0861-2019 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: 14.
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
- 14
Product Description
PageWriter TC30 w/o trolley Government Bundle, Product 860355, 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
US31510433 US31630351 US31630352 US31630353 US51510712 US51510713 US61510947 US61630668 US61630669 US81731977 US81731978 US91511381 US91511445 USO1511461