GE Healthcare began the recall of Carescape respiratory modules and Airway Gas Option NCAiO units in September 2019 because faulty oxygen sensors may cause them to display incorrect patient oxygen levels, according to the agency. Patients could develop long-term high or low blood-oxygen levels, which could result in organ damage, tissue injury, increased chance of infection, or death, the FDA said. There have been no reported injuries or deaths.
This is the second time within two weeks that GE Healthcare’s Carescape devices have been in the news. On Jan. 23, the federal government and and the company announced that some versions of the Carescape and ApexPro telemetry servers, the Carescape Central Station version 1 and Central Information Center systems are vulnerable to cyberattack.
The recall just designated a Class I covers eight models of the Carescape respiratory module that can be used with the following GE Healthcare devices:
- Carescape B850, B650 and B450 patient monitors.
- B40(i), B105, B125 patient monitors.
- Avance CS2 and Aisys CS2 anesthesia Carestation.
- Carestation 620, 650, 650c for anesthesia.
- Carescape R860 ventilator for critical care.
- S/5 modular monitors.
The Airway Gas Option may be used with the company’s B40(i), B105, B125 patient monitors and with its Carestation 620, 650, 650c for anesthesia.
The U.S. recall covers 167 Carescape modules and 12 Airway Gas Option units, but the field safety notice was sent to GE Healthcare customers in several other countries as well.
“Patient safety is our top priority,” the company said in an email to MassDevice. “As of today, the company has not received reports of these units failing in clinical use. There are no reports of injuries associated with this issue.”