Class I Recall for External Defibrillators | 06.07.12 |
An alert to emergency services personnel and risk managers about a Class I recall of Welch Allyn PIC 50 Automated External Defibrillators - catalog #97108X- was announced Monday by the U.S. Food and Drug Administration. The devices, manufactured from March 2002 through October 2004, have an electrical contact problem that may result in failure to provide a defibrillation shock. This could result in delay or failure to resuscitate a patient, the FDA said. The device's failure to provide a defibrillation shock may be accompanied by various error messages on the display panel, such as the "Defib Comm" error message. A Class I recall is the most serious type of recall and involves situations in which there is a reasonable probability that use of the recalled product will cause serious injury or death. People with questions about the recall can contact the company at (800) 462-0777 or (847) 520-0300. |