The FDA slapped Spacelabs Healthcare with a Class I recall after the medical device company pulled 16 of is Arkon anesthesia delivery devices due to a software bug.
The recall, of the Arkon device equipped with version 2.0 software, involves devices sold to hospitals in North Carolina and South Carolina, according to the FDA. The Class I recall status denotes a problem that could cause serious injury or death.
"This software issue may cause the system to stop working and require manual ventilation of patients," according to the FDA. "In addition, if a cell phone or other USB device is plugged into 1 of the 4 USB ports for charging, this may also cause the system to stop working."
The recall affects serial nos. ARKN-000011, ARKN-000016, ARKN-000017, ARKN-000019, ARKN-000020, ARKN-000021, ARKN-000022, ARKN-000023, ARKN-000024, ARKN-000025, ARKN-000026, ARKN-000027, ARKN-000028, ARKN-000029, ARKN-000030, and ARKN-000031, the federal watchdog agency said.
It’s the 2nd recall in as many years for Spacelabs. In July 2013, the FDA put Class II status on a recall of the Arkon anesthesia workstation, also due to a software problem.