FDA (Devices) recall action 97441
The FDA (Devices) publishes a recall like this one as 23 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 23 pages.
Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
The agency’s own wording, quoted from the enforcement report.
Olympus is recalling EVIS EXERA III Bronchovideoscope BF-P190 units for instructions-for-use updates on safe use with laser, argon plasma coagulation and high-frequency therapy equipment.
Olympus is recalling EVIS EXERA II Bronchovideoscope BF Type Q180-AC units for instructions-for-use updates on safe use with laser, argon plasma coagulation and high-frequency therapy equipment.
Olympus is recalling EVIS EXERA III Bronchovideoscope BF-H190 units for instructions-for-use updates on safe use with laser, argon plasma coagulation and high-frequency therapy equipment.
Olympus is recalling Bronchofiberscope BF Type PE2 units for instructions-for-use updates on safe use with laser, argon plasma coagulation and high-frequency therapy equipment.
Olympus is recalling EVIS EXERA Bronchovideoscope BF Type XT160 units for instructions-for-use updates on safe use with laser, argon plasma coagulation and high-frequency therapy equipment.
Olympus is recalling Bronchovideoscope BF-XT190 units for instructions-for-use updates on safe use with laser, argon plasma coagulation and high-frequency therapy equipment.
Olympus is recalling Bronchovideoscope BF-1TQ170 units for instructions-for-use updates on safe use with laser, argon plasma coagulation and high-frequency therapy equipment.
Olympus is recalling Bronchovideoscope BF Type 1T150 units for instructions-for-use updates on safe use with laser, argon plasma coagulation and high-frequency therapy equipment.
Olympus is recalling Bronchovideoscope BF-H1100 units for instructions-for-use updates on safe use with laser, argon plasma coagulation and high-frequency therapy equipment.
Olympus is recalling OES Bronchofiberscope BF Type XT40 units for instructions-for-use updates on safe use with laser, argon plasma coagulation and high-frequency therapy equipment.
Olympus is recalling EVIS EXERA III Bronchovideoscope BF-Q190 units for instructions-for-use updates on safe use with laser, argon plasma coagulation and high-frequency therapy equipment.
Olympus is recalling OES Bronchofiberscope BF Type MP60 units for instructions-for-use updates on safe use with laser, argon plasma coagulation and high-frequency therapy equipment.
Olympus is recalling EVIS EXERA III Bronchovideoscope BF-1TH190 units for instructions-for-use updates on safe use with laser, argon plasma coagulation and high-frequency therapy equipment.
Olympus is recalling EVIS EXERA II Bronchovideoscope BF Type Q180 units for instructions-for-use updates on safe use with laser, argon plasma coagulation and high-frequency therapy equipment.
Olympus is recalling Bronchovideoscope BF Type P150 units for instructions-for-use updates on safe use with laser, argon plasma coagulation and high-frequency therapy equipment.
Olympus is recalling OES Bronchofiberscope BF Type 1T60 units for instructions-for-use updates on safe use with laser, argon plasma coagulation and high-frequency therapy equipment.
Olympus is recalling EVIS EXERA II Bronchovideoscope BF Type P180 units for instructions-for-use updates on safe use with laser, argon plasma coagulation and high-frequency therapy equipment.
Olympus is recalling OES Bronchofiberscope BF Type P60 units for additional instructions-for-use updates clarifying safe use with laser, argon plasma coagulation and high-frequency therapy equipment.
Olympus is recalling Bronchofiberscope BF Type TE2 units for instructions-for-use updates on safe use with laser, argon plasma coagulation and high-frequency therapy equipment.
Olympus is recalling Bronchovideoscope BF-1TH1100 units for instructions-for-use updates on safe use with laser, argon plasma coagulation and high-frequency therapy equipment.
Olympus is recalling Bronchovideoscope BF-Q170 units for instructions-for-use updates on safe use with laser, argon plasma coagulation and high-frequency therapy equipment.
Olympus is recalling EVIS EXERA II Bronchovideoscope BF Type 1T180 units for instructions-for-use updates on safe use with laser, argon plasma coagulation and high-frequency therapy equipment.
Olympus is recalling EVIS EXERA II Bronchovideoscope BF Type 1TQ180 units for instructions-for-use updates on safe use with laser, argon plasma coagulation and high-frequency therapy equipment.