FDA (Devices) recall action 80925
The FDA (Devices) publishes a recall like this one as 30 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 30 pages.
The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Olympus is recalling 5,545 Bronchofiberscope BF-P60 units because attaching non-Olympus accessories may cause the instrument channel port to loosen.
Olympus is recalling 817 Bronchofiberscope BF-XP40 units because using non-Olympus accessories may loosen the instrument channel port.
Olympus is recalling 2,803 Bronchovideoscope BF-1T60 units because using non-Olympus accessories may loosen the instrument channel port.
Olympus is recalling 3,701 Rhino Laryngo scope ENF-VT2 units because using non-Olympus accessories may loosen the instrument channel port.
Olympus is recalling 3,705 Bronchovideoscope BF-P180 units because non-Olympus accessories may have caused the instrument channel port to loosen.
Olympus is recalling 5,845 Bronchovideoscope BF-Q180 units because using non-Olympus accessories may have caused the instrument channel port to loosen.
Olympus is recalling 5,607 Bronchofiberscope BF-P40 units because attaching non-Olympus accessories may loosen the instrument channel port.
Olympus is recalling 1,874 Bronchovideoscope BF-P160 units because using non-Olympus accessories may loosen the instrument channel port.
Olympus is recalling 5,810 Bronchovideoscope BF-1T180 units because non-Olympus accessories may cause the instrument channel port to loosen.
Olympus is recalling 3,317 Bronchofiberscope F-1T160 units because using non-Olympus accessories may loosen the instrument channel port.
Olympus is recalling 672 Bronchovideoscope BF-MP160F units because using non-Olympus accessories may loosen the instrument channel port.
Olympus is recalling 1,347 Bronchofiberscope BF-40 units because attaching non-Olympus accessories may loosen the instrument channel port.
Olympus is recalling 3,948 Bronchovideoscope BF-160 units because attaching non-Olympus accessories may loosen the instrument channel port.
Olympus is recalling 197 Bronchofibercope BF-6C240 units because non-Olympus accessories may have caused the instrument channel port to loosen.
Olympus is recalling 653 Bronchovideoscope BF-MP60 units because non-Olympus accessories may cause the instrument channel port to loosen.
Olympus is recalling 3,456 Airway Mobilescope MAF-TM units because attaching non-Olympus accessories may loosen the instrument channel port.
Olympus is recalling 879 ultrasonic bronchoscopes because attaching non-Olympus accessories may loosen the instrument channel port.
Olympus is recalling 2,318 Bronchovideoscope BF-3C160 units because attaching non-Olympus accessories may have caused the instrument channel port to loosen.
Olympus is recalling 3,041 Bronchovideoscope BF-1T40 units because using non-Olympus accessories may loosen the instrument channel port.
Olympus is recalling 1,134 Bronchovideoscope F-1TQ180 units because attaching non-Olympus accessories may cause the instrument channel port to loosen.
Olympus is recalling 4,785 Ultrasonic Bronchoscopes BF-UC180F because using non-Olympus accessories may loosen the instrument channel port.
Olympus is recalling 1,605 Bronchovidescope BF-1T240 units because attaching non-Olympus accessories may have loosened the instrument channel port.
Olympus is recalling 655 Bronchovideoscope BF-Q180-AC units because using non-Olympus accessories may have loosened the instrument channel port.
Olympus is recalling 931 Bronchofiberscope BF-XT40 units because attaching non-Olympus accessories may cause the instrument channel port to loosen.
Olympus is recalling 1,467 Bronchovideoscope BF-240 units because attaching non-Olympus accessories may loosen the instrument channel port.