FDA (Devices) recall action 81957
The FDA (Devices) publishes a recall like this one as 9 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 9 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Philips is recalling 57 PageWriter TC70 cardiographs because end-of-life batteries may overheat, melt, or ignite, posing a risk of injury to patients and users.
Philips is recalling PageWriter TC50 electrocardiogram devices because end-of-life batteries may overheat, melt the case, or ignite, posing a risk of injury to patients and users.
Philips is recalling PageWriter TC30 cardiographs because end-of-life batteries may overheat, melt, or ignite, posing injury risks to patients and users.
Philips is recalling PageWriter TC20 devices because end-of-life batteries may overheat, melt the case, or ignite, posing a risk of injury.
Philips is recalling PageWriter TC30 cardiographs because end-of-life batteries may overheat, melt, or ignite, posing injury risks to patients and users.
Philips is recalling PageWriter TC50 devices because end-of-life batteries may overheat, melt, or ignite, posing injury risks to patients and users.
Philips is recalling PageWriter TC30 ECG devices because end-of-life batteries may overheat, melt the case, or ignite, posing injury risks to patients and users.
Philips is recalling PageWriter TC70 cardiographs because end-of-life batteries may overheat, melt, or ignite, posing injury risks to patients and users.
Philips is recalling PageWriter TC70 cardiographs because end-of-life batteries may overheat, melt the case, or ignite, posing a risk of injury to patients and users.