The Food and Drug Administration (FDA), on August 30, identified the recall by Hamilton Medical of its HAMILTON-C1, C2, C3, and T1 ventilators as Class I, the most serious.
The recall was initiated because of software issues that may cause the ventilators to stop without notice.
There have been 80 complaints, no injuries, and no deaths reported.
Distribution dates were December 10, 2010, to May 1, 2023.
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