| Health / Medical Topics |
Manufacturing or Shipping Issue Associated with Medical Device
Issue associated with any deviations from device documented performance specifications relating to non-conformity during manufacture to the design of an item or to specified manufacturing processes. (Food and Drug Administration)
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The device manufacturer had recognized a recurrent performance failure in the device.
An imperative issued by the manufacturer of a device that the device needs to be returned to a designated source for repair…
A person, enterprise, or entity that produces finished goods.
A physical object created by hand or machine.
