Medical Device Safety and Recalls: FDA Recommends Health Care Facilities Transition from Custom Ultrasonics Endoscope Washer/Disinfectors to Alternate Reprocessing Methods: FDA Safety Communication

Today, the FDA issued the Safety Communication, “FDA Recommends Health Care Facilities Transition from Custom Ultrasonics Endoscope Washer/Disinfectors to Alternate Reprocessing Methods
to notify health care professionals about our concerns with the safety and effectiveness of all Custom Ultrasonics’ AER models. This communication provides recommended actions health care facilities should take if they use Custom Ultrasonics’ AERs because of the risk of transmission of infectious organisms to patients.

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