The FDA has issued an update for health care facilities that suspended the use of Custom Ultrasonics’ endoscope washer/disinfectors over the past several months along with recommendations on returning the devices to service.

In January, Custom Ultrasonics Inc agreed to stop manufacturing and distributing all devices it manufactures, including the System 83 Plus washer/disinfector, the System 83 Plus MiniFlex washer/disinfector, and all accessories when the FDA issued a Consent Decree to the company.

In May, the FDA followed up by stating that the company has now complied with the requirements of the Consent Decree and is permitted to resume manufacturing the System 83 Plus washer/disinfector and all accessories. The firm has also been found to be in substantial compliance with the Medical Device Reporting regulation.

The FDA recommends that prior to returning the devices to service, the company’s service department should come out to perform the start up maintenance procedures and verify the safety and effectiveness of the devices. Facilities can contact the firm’s service department at (215) 364-1477 about performing these procedures at no cost.

The agency announced that the check is an important step to take prior to putting the device back into service to ensure that a high level of bacterial contamination did not develop inside the device while it was sitting idle, as well as assuring that the device is operating within specifications.

Users are urged to report any concerns or questions about how the device is functioning to Custom Ultrasonics immediately.

The complete notification can be found online.