Philips HeartStart products
Philips Healthcare has issued a worldwide recall of batteries for its HeartStart MRx monitor/defibrillator.
The Philips M3538A lithium-ion batteries manufactured from December 28, 2017 to March 20, 2018 for the HeartStart MRx monitor/defibrillator may have an internal component failure and may fail to charge or to provide power, according to a statement by the U.K. Medicines and Healthcare products Regulatory Agency. The FDA had not released a statement of its own.
“The supply of batteries for these devices has been halted again due to further manufacturing problems,” the British new advisory says. “There is likely to be an ongoing significant delay in the fulfillment of outstanding orders.”
The U.K. health agency said that its alert is related to a January 15, 2018 advisory that said the batteries were in short supply, but that Philips had expected to resume shipments by January 23, 2018.
Philips said it has notified regulatory agencies in countries in which these batteries have been distributed and is providing a field safety notice to inform customers about the issue and under what conditions it can occur. Philips is advising customers to immediately remove affected batteries from service. The recall covers 1,880 batteries worldwide.
The company said it has received no reports of patient or user harm due to this potential issue and that customers contact Philips if their device fails to function as intended.
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