PageWriter TC70, Product 860315, Software revisions up to and including A.07.05.22 used to evaluate the electrocardiogram of adult and pediatric patients
Reported: February 27, 2019 Initiated: January 9, 2019 #Z-0853-2019
Product Description
PageWriter TC70, Product 860315, Software revisions up to and including A.07.05.22 used 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.
Details
- Recalling Firm
- Philips North America, LLC
- Units Affected
- 15,064
- Distribution
- Domestic distribution nationwide. Foreign distribution worldwide.
- Location
- Andover, MA
Frequently Asked Questions
What product was recalled? ▼
PageWriter TC70, Product 860315, Software revisions up to and including A.07.05.22 used to evaluate the electrocardiogram of adult and pediatric patients. Recalled by Philips North America, LLC. Units affected: 15,064.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 27, 2019. Severity: Moderate. Recall number: Z-0853-2019.
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