A Massachusetts company is recalling 10,000 automated external defibrillators because they didn’t work properly and, at times, turned themselves on automatically.
Access CardioSystems Inc. is recalling automated external defibrillators that are used by fire departments and hospitals around the nation. Some of the devices are currently in use, while others remained at distributors awaiting shipment.
“They’re no longer in business. They can’t correct the product. They can’t service it. And they can’t replace it,” said Susan Liner, the Food and Drug Administration’s recall coordinator for the New England district.
The automated external defibrillators being recalled failed in two ways. No patient died because of either type of malfunction, the company said.
The device’s shock delivery circuit experienced “catastrophic failure,” making it impossible to deliver defibrillation shocks. So far, the company has received 11 complaints, but an estimated 1,450 units may fail in the same way. The problematic devices carry serial numbers from 075690 to 077140.
Other defibrillators mysteriously turned themselves on. In these devices, the on-off button simultaneously stopped working. So far, 33 complaints were recorded, but an estimated 9,580 units may fail in the same way. The faulty devices carry serial numbers from 075180 to 084760.
Customers should immediately stop using the recalled devices.
The company no longer will manufacture or market any of its defibrillators — even those not subject to recall. Nor can it accept orders for components, like disposable battery packs and electrode sets.
Customers with Access CardioSystems devices not subject to recall should replace them.
People with questions can call 978-405-1057 or e-mail the company at firstname.lastname@example.org.