Zoll Medical, FDA issue Class 1 defibrillator recall
Zoll Medical and the FDA have notified healthcare professionals of a Class 1 recall of Zoll AED [automated external defibrillator] Plus Defibrillators distributed from May 2004 through Feb. 9, 2009. The recall 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.
On Feb. 12 and March 31, the Chelmsford, Mass.-based company sent their distributors and customers recall letters with recommendations and instructions for customers on specific steps to mitigate the identified problems with this device.
The device is used by emergency or medical personnel, by others who have completed CPR AED training courses, or the public at large. The device is intended to treat patients in cardiac arrest, and analyzes an unconscious patient's heart rhythm.
Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death, according to the FDA.
On Feb. 12 and March 31, the Chelmsford, Mass.-based company sent their distributors and customers recall letters with recommendations and instructions for customers on specific steps to mitigate the identified problems with this device.
The device is used by emergency or medical personnel, by others who have completed CPR AED training courses, or the public at large. The device is intended to treat patients in cardiac arrest, and analyzes an unconscious patient's heart rhythm.
Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death, according to the FDA.