Philips Korea has stopped the sales of three of its automated external defibrillator (AED) products following the decision of Philip North America.
Philips North America recently ceased operation in the U.S. for specific products after entering a consent decree with the Food and Drug Administration (FDA). The three products are HeartStart FRx, Heartstart Laerdal and HeartStart XL+.
Philips Korea 필립스코리아 said the decision had nothing to do with the performance of the machine and did not pose any health risks to the patients.
“The cease in sales was not due to equipment defect, but rather because of an update of the facility to comply with the FDA’s quality system regulation (QSR),” a company spokesperson told Korea Biomedical Review over the phone Monday. “No restrictions were placed on existing products and services for those products are still available.”
After the facility gets certified by the FDA following the inspection of the facilities’ compliance with the QSR, the company is set to resume the suspended defibrillator production next year, according to a statement released by Philips Headquarters on Oct. 11. After the FDA approval, Philips Korea aims to win certification from the Ministry of Food and Drug Safety (MFDS) before resuming sales, the spokesperson added.
Meanwhile, the FDA issued a class 1 recall order on 47,362 HeartStart MRx products, made from Feb. 11, 2004, to Nov. 4, 2016, on Feb. 24. The recall was due to the product having electrical and battery connection problems that may prevent the device from powering up, charging, and delivering an electrical shock therapy.
In the U.S. customers received an urgent medical device correction notice, which included instructions to update the device’s software.
After the recall in the U.S., the Korean ministry also sent out safety notice to re-inspect and update the software for 1,486 product used in Korea in April.
Currently, about 60 percent of the product has been updated, the spokesperson said.
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