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 its Spectrum Medical Ltd. Quantum Perfusion Systems for CPB [Catalogue number: 51-000013-00, 51-000008-00] [HKMD No.: 210220].
According to the FDA, the ratchet and pawl had an out of tolerance geometry which exhibited as the left bobbin would not lock.
For further information, please visit: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=95428
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 28 Oct 2024