EVIS EXERA III Duodenovideoscope Recalled Due to Patient Infection Reports
Olympus Corporation recalls 6,426 units of the EVIS EXERA III Duodenovideoscope (Model TJF-Q190V) due to recent reports of patient infections. The device was distributed nationwide in the United States.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class II medical device with reported patient infections, which constitute significant injury reports warranting immediate action.
Plain-English summary
The Olympus Corporation of the Americas is recalling 6,426 units of the EVIS EXERA III Duodenovideoscope, Model TJF-Q190V, due to recent reports of patient infections associated with the device. The device was distributed nationwide in the United States.
The recalled units are identified by Model No. TJF-Q190V and UDI-DI 04953170405563. Healthcare providers and facilities that use this device should contact Olympus Corporation of the Americas for recall instructions.
Patients who have undergone procedures using this device should consult their healthcare provider if they have concerns about a potential infection. Any patient experiencing symptoms of infection following a procedure using this device should seek immediate medical attention.
The recalled product
- Product
- EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Endoscope
- Hazard
- Affected units
- 6,426
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. TJF-Q190V
- UDI-DI: 04953170405563
- All Serial No.
Distribution
Distributed nationwide across the United States.
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