Olympus Bronchoscope Instruction Updates for Safe Therapeutic Equipment Use
Olympus Corporation recalled the EVIS EXERA III bronchoscope (4,297 US units; 4,290 international units) for instruction clarification regarding safe use with laser, argon plasma coagulation, and high-frequency therapy equipment.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recall classification requires a minimum score of 4 per recall guidelines. No illnesses, injuries, or deaths are documented in the source material. The recall is precautionary, addressing instruction clarification rather than an actual device defect.
Plain-English summary
Olympus Corporation of the Americas issued a Class I recall of the EVIS EXERA III BF-1TH190 bronchoscope. Approximately 4,297 units were distributed throughout the US, with an additional 4,290 units distributed internationally.
The recall was initiated to provide additional clarification in the instructions for use (IFU) regarding the safe and effective operation of the bronchoscope when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
Healthcare providers and facilities using this bronchoscope model should obtain the updated instructions for use from Olympus Corporation to ensure proper and safe use with the specified therapeutic equipment modalities.
The recalled product
- Product
- EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-1TH190
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Endoscopy
- Hazard
- instruction-clarification-needed
- equipment-interaction-safety
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model No. BF-1TH190
- UDI: 4953170434778
- All Serial No.
Distribution
Distributed nationwide across the United States.
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