Carescape (respiratory analyzers)

2020: A withdrawal of the rejected respiratory analyzers

At the beginning of February, 2020 GE Healthcare announced a withdrawal of the rejected respiratory analyzers used when monitoring patients. The response was carried to the I class, i.e. the most serious type of responses, with threat of life of the patient.

GE Healthcare began a withdrawal of the respiratory modules Carescape and the Airway Gas Option NCAiO blocks in September, 2019 as faulty sensors can display the wrong values of oxygen at the patient. As a result at patients the long hypoxia or a giperoksiya capable to lead to serious damage of bodies and fabrics can develop, to increase the probability of an infection or death. So far messages about injuries or fatal cases did not arrive.

GE Healthcare announced a withdrawal of the rejected respiratory analyzers

The withdrawal of the I class covers eight models of the respiratory module Carescape which are used with the following GE Healthcare devices: monitors of the patient Carescape B850, B650 and B450, the B40 (i), B105, B125 monitors, Avance CS2 and Aisys CS2 anesthetics, systems for an anesthesia of Carestation 620, 650, 650c, the Carescape R860 medical ventilator, the modular S/5 monitors. The Airway Gas Option NCAiO blocks it is used with monitors of the patient of B40 (i), B105, B125 and with systems for an anesthesia of Carestation 620, 650, 650c.

The response covers 167 modules Carescape and 12 modules Airway Gas Option NCAiO in the USA, but the notice on security on places was sent to clients of GE Healthcare and in some other countries.

Safety of patients is our main priority, says MassDevice company. - Today the company did not receive bounce messages of these devices at clinical use. Messages about the injuries connected with this problem also did not arrive.

GE Healthcare Carescape devices appeared in news twice in a month. In January, 2020 the company ojyavit that a number of the systems of telemetry of Carescape and ApexPro were vulnerable for cyber attack. The company already undertook counter-measures.^[1]

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