Reported Feb 27, 2019 · Ongoing

PageWriter TC20, Product 860332, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of…

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 TC20, Product 860332, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients
Lot codes and dates
  • 2,717 of 2,717 codes

    • CN11201318
    • CN11201319
    • CN11201320
    • CN11201321
    • CN11201322
    • CN11201323
    • CN11201324
    • CN11201325
    • CN11201326
    • CN11201327
    • CN11201328
    • CN11201329
    • CN11201330
    • CN11201331
    • CN11201332
    • CN11201333
    • CN11201334
    • CN11201335
    • CN11201336
    • CN11201337
    • CN11201338
    • CN11201339
    • CN11201340
    • CN11201341
    • CN11201342
    • CN11201343
    • CN11201344
    • CN11201345
    • CN11201346
    • CN11201347
    • CN11201348
    • CN11201349
    • CN11201350
    • CN11201351
    • CN11201352
    • CN11201353
    • CN11201354
    • CN11201355
    • CN11201356
    • CN11201357
    • CN11201358
    • CN11201359
    • CN11201360
    • CN11201361
    • CN11201362
    • CN11201363
    • CN11201364
    • CN11201365
    • CN11201366
    • CN11201371
    • CN11201372
    • CN11201373
    • CN11201374
    • CN11201375
    • CN11201376
    • CN11201377
    • CN11201378
    • CN11201379
    • CN11201380
    • CN11201381
Amount recalled
14067

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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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:34 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.