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

    • CN11102314
    • CN11102315
    • CN11102316
    • CN11102317
    • CN11203436
    • CN11203443
    • CN11203444
    • CN11203453
    • CN11203454
    • CN11203455
    • CN11304748
    • CN11304749
    • CN11304762
    • CN11304772
    • CN11304773
    • CN11304802
    • CN11304803
    • CN11304805
    • CN11304806
    • CN11304809
    • CN11406020
    • CN11406033
    • CN11406034
    • CN11507236
    • CN11507237
    • CN11507238
    • CN11507259
    • CN11507260
    • CN11507261
    • CN11507262
    • CN11507263
    • CN11507264
    • CN11630099
    • CN11630100
    • CN11630101
    • CN11630102
    • CN11630103
    • CN11630104
    • CN11630105
    • CN11630106
    • CN11630107
    • CN11630108
    • CN11630109
    • CN11630110
    • CN11630111
    • CN11630112
    • CN11630113
    • CN11630114
    • CN11630122
    • CN11630123
    • CN11630124
    • CN11630125
    • CN11630126
    • CN11630128
    • CN11630129
    • CN11630130
    • CN11630131
    • CN11630132
    • CN11630133
    • CN11630134
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.

Want the full recall guide?

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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:35 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.