Reported Feb 27, 2019 · Ongoing
PageWriter TC50, Product 860310, 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 TC50, Product 860310, 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
CN11102314CN11102315CN11102316CN11102317CN11203436CN11203443CN11203444CN11203453CN11203454CN11203455CN11304748CN11304749CN11304762CN11304772CN11304773CN11304802CN11304803CN11304805CN11304806CN11304809CN11406020CN11406033CN11406034CN11507236CN11507237CN11507238CN11507259CN11507260CN11507261CN11507262CN11507263CN11507264CN11630099CN11630100CN11630101CN11630102CN11630103CN11630104CN11630105CN11630106CN11630107CN11630108CN11630109CN11630110CN11630111CN11630112CN11630113CN11630114CN11630122CN11630123CN11630124CN11630125CN11630126CN11630128CN11630129CN11630130CN11630131CN11630132CN11630133CN11630134
- Amount recalled
- 11332
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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