The FDA today announced that Custom Ultrasonics completed validation testing of its System Plus automated endoscope reprocessors, and that the devices are cleared for the reprocessing of certain duodenoscopes. With the clearance, the Philadelphia-based company’s line of System 83 Plus AERs are cleared for washing and disinfecting the Olympus (TYO:7733) TJF-180V and Pentax ED-3490TK duodenoscopes, according to an FDA […]
Custom Ultrasonics
FDA clears Custom Ultrasonics to resume manufacturing System 83 endoscope washer-disinfector
Custom Ultrasonics said yesterday that the FDA inspected and cleared its manufacturing facility in Ivyland, Penn, reinstating the manufacturing, packing and distribution of the company’s System 83 Plus washer and disinfector for use with non-duodenoscope endoscopes. The Philadelphia-based company said that it was required to perform independent validation testing for its System 83 Plus water filtration […]
FDA warns on using Custom Ultrasonics device on duodenoscopes
The FDA today reiterated its warning not to use the an automated endoscope reprocessor made by Custom Ultrasonics with a type of ‘scope called duodenoscopes, which have been linked to deadly “superbug” outbreaks. Although the federal safety watchdog lifted the recall on Custom Ultrasonics’ endoscope reprocessors while the company looked to correct the violations that prompted the recall, the […]
FDA lifts recall on Custom Ultrasonics endoscope reprocessors
Custom Ultrasonics said today that the FDA lifted the recall on its endoscope reprocessors while the company looks to correct the violations that prompted the recall. Ivyland, Pa.-based Custom Ultrasonics said the action allows its devices to remain in the field to clean and sterilize endoscopes, excluding a type called duodenoscopes that caused a string of […]
FDA orders recall of all Custom Ultrasonics endoscope reprocessors
The FDA today ordered Custom Ultrasonics to recall all of its automated endoscope reprocessors over “continued violations of federal law and a consent decree entered with the company in 2007.” The agency said the violations could result in an increased risk of infection transmission. The FDA said that the recall was under terms of the […]
