Reported Feb 27, 2019 · Ongoing
PageWriter TC70, Product 860315, Software revisions up to and including A.07.05.22 used to evaluate the…
Philips North America, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips North America, LLC · 3000 Minuteman Rd · Andover, MA · 01810-1032
Is this the product you have?
- PageWriter TC70, Product 860315, Software revisions up to and including A.07.05.22 used to evaluate the electrocardiogram of adult and pediatric patients
- Lot codes and dates
2,717 of 2,717 codes
CN80811000CN80811001F5N7000106F5N7000107F5O7000002F5O7000024F5O7000027F5O7000037F5O7000078F5O7000085F5O7000091F5O7000093US10901771US10901772US10901773US10901774US10901775US10901776US10901777US10901778US10901779US10901782US10901783US10901784US10901785US10901786US10901787US10901788US10901789US10901790US10901791US10901792US10901793US10901794US10901795US10901796US10901797US10901798US10901799US10901800US10901801US10901802US10901803US10901804US10901805US10901806US10901807US10901808US10901809US10901810US10901811US10901812US10901813US10901814US10901815US10901816US10901817US10901818US10901819US10901821
- Amount recalled
- 15,064
This recall covers 9 products
The agency filed one notice per product. You are reading one of them; the other 8 are below.
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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