Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
The United States Food and Drug Administration (FDA) has posted a medical device safety alert concerning Datex-Ohmeda, Inc. (GE HealthCare) EVair and EVair 03 (Jun-air) Compressors with The CARESCAPE R860 ventilator or Engström Carestation/Pro ventilators [HKMD numbers: 160259].
According to the FDA, the manufacturer has reported that the potential for elevated levels of formaldehyde based on preliminary testing when the EVair or EVair 03 (Jun-air) optional compressors are used with the Carescape R860 or Engström Carestation/Pro ventilators, respectively.
For further information, please visit https://www.fda.gov/medical-devices/letters-health-care-providers/potential-exposure-certain-chemicals-use-ge-healthcare-evair-and-evair03-compressors-certain
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 11 Jan 2024