News Tagged ‘Class I recall

FDA issues Class I recall for faulty pacemakers

The Food and Drug Administration () has issued an alert to patients just two weeks after Medtronic, Inc. sent separate letters to health care professionals and patients worldwide warning that thousands of its pacemakers could have faulty wiring that can cause the medical devices to work improperly or not work at all. This defect could have potentially deadly consequences for patients with the devices.

Read the rest of this entry »

FDA issues Class I recall on ZOLL heart defibrillator

Another heart defibrillator has fallen under a Class I by the Food and Drug Administration (). The on ZOLL AED Plus was initiated because the device may fail to deliver a defibrillation shock, which could result in failure to resuscitate a patient during treatment of sudden cardiac arrest.

Read the rest of this entry »