Olympus Promises Swift Action After Hardware Blocked by FDA

Olympus promises swift action after hardware blocked by FDA

Olympus is promising swift action to address concerns raised by the Food and Drug Administration (FDA) about some of its medical scopes.

Olympus pledges prompt response following FDA import block

Endoscopy devices restricted from import accounted for about 1% of the company’s consolidated revenue in its latest fiscal year, Olympus said.

Olympus Acknowledges FDA Import Alerts for Certain Devices - TechNation

On June 24, the U.S. Food and Drug Administration (FDA) published import alerts for certain medical devices manufactured at the company’s Aizu facility in Fukushima, Japan. This action prevents the import of the specified devices into the U.S. until further notice. The devices affected include certain bronchoscopes, laparoscopes, ureterorenoscopes, and automated endoscope reprocessors. Olympus is

FDA Stops Olympus Devices From Entering The US - Data Intelligence

Listen to the article 2 min This audio is auto-generated. Please let us know if you have feedback. Dive Brief: The Food and Drug Administration has blocked certain Olympus Medical devices from entering the U.S. because of quality system failings at a site in Japan. FDA officials issued the import alerts Tuesday to prevent 58 models of Olympus devices used in urinary, respiratory, abdominal and pelvic procedures from reaching customers in the U…