- 8,009
- 58
- 48
Recall:
MRL Inc. Issues Voluntary Recall of AED20
May 17 , 2005
On May 10, MRL Inc., a Welch Allyn Company, announced a voluntary worldwide recall of AED20 AEDs manufactured in Buffalo Grove, Ill., between February and July 2004. These 597 devices—296 of which were sold within the United States and 301 outside of the United States—may display a “Defib Comm” error message on the display during use, resulting in a failure of the device to analyze the patient’s ECG and deliver the appropriate therapy, potentially preventing resuscitation. The problem occurs when an impact to the exterior of the AED20 causes a circuit board connector to perforate an insulation shield, creating an electrical short between the connector and the external housing of the AED20, according to a company press release.
The company has received 12 related complaints with this specific group of AED20s, including one instance in which the short may have prevented patient resuscitation. The company has taken corrective action and no other devices besides those manufactured between the above dates are subject to this voluntary recall.
MRL Inc. initiated notification via certified mail on May 5 to its customers who purchased affected AED20s. It is also providing customers with a loaner AED20 at no cost while their unit is being serviced and will pay all costs associated with shipping, handling and corrective service.
This recall is being conducted with the full knowledge of the U.S. Food and Drug Administration (FDA). FDA has determined that this action is a Class 1 recall. The FDA defines Class 1 as a situation in which there is reasonable probability that the use of or exposure to the product will cause serious adverse health consequences or death.
Customers with questions may contact the company at 800/462-0777.
Clicky
~Jems
MRL Inc. Issues Voluntary Recall of AED20
May 17 , 2005
On May 10, MRL Inc., a Welch Allyn Company, announced a voluntary worldwide recall of AED20 AEDs manufactured in Buffalo Grove, Ill., between February and July 2004. These 597 devices—296 of which were sold within the United States and 301 outside of the United States—may display a “Defib Comm” error message on the display during use, resulting in a failure of the device to analyze the patient’s ECG and deliver the appropriate therapy, potentially preventing resuscitation. The problem occurs when an impact to the exterior of the AED20 causes a circuit board connector to perforate an insulation shield, creating an electrical short between the connector and the external housing of the AED20, according to a company press release.
The company has received 12 related complaints with this specific group of AED20s, including one instance in which the short may have prevented patient resuscitation. The company has taken corrective action and no other devices besides those manufactured between the above dates are subject to this voluntary recall.
MRL Inc. initiated notification via certified mail on May 5 to its customers who purchased affected AED20s. It is also providing customers with a loaner AED20 at no cost while their unit is being serviced and will pay all costs associated with shipping, handling and corrective service.
This recall is being conducted with the full knowledge of the U.S. Food and Drug Administration (FDA). FDA has determined that this action is a Class 1 recall. The FDA defines Class 1 as a situation in which there is reasonable probability that the use of or exposure to the product will cause serious adverse health consequences or death.
Customers with questions may contact the company at 800/462-0777.
Clicky
~Jems
