Olympus America Video Bronchoscopes
Audience: Hospital Administrators, Risk Managers, Pulmonologists
The FDA Center for Devices and Radiological Health notified healthcare professionals of a voluntary recall of Olympus America, Inc. bronchoscopes after a medical facility reported bacteria growth which possibly caused two illnesses. The bronchoscopes were distributed nationwide between June 5, 1997 and December 10, 2001.
Olympus issued a recall notification letter to hospitals and medical facilities about the suspect bronchoscopes on November 30, 2001, requesting they be returned to Olympus for modification. On February 27, 2002, Olympus issued a second recall notification letter to facilities that did not respond to their first letter. See the complete FDA/CDRH notification for additional information, including specific model numbers affected.
[March 20, 2002 - Device Recall - FDA]