Medical technology company Stryker is recalling units of the LIFEPAK 15 Monitor/Defibrillators after a malfunction that could cause the device to lock up after a defibrillation shock is delivered.
The company is notifying affected customers to update their devices, the Food and Drug Administration said in a press release Monday.
During the malfunction, the device's monitor appears blank, but its LED lights remain on, indicating that the power is still on, however there is no response from the keypad or device function, the FDA said.
Since 2009, the company has recorded six deaths and 58 complaints globally linked to the malfunction problem. Stryker said the six deaths appear related to the lockup malfunction.
More than 13,000 devices are potentially impacted by the recall. The company is advising patients to continue using their devices as usual until it can fix the problem.
"The company is instructing customers to continue to use their LIFEPAK 15 Monitor/Defibrillator according to the Operating Instructions until the correction can be completed," the FDA press release said.
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