Olympus EVIS EXERA III Video System Recalled for Startup Failure
Olympus is recalling 45 units of the EVIS EXERA III Video System Center (Model CV-190) that fail to start due to power supply defects. The endoscopy device was distributed nationwide.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device with a manufacturing defect preventing operation. Although no injuries or illnesses have been reported, a non-functional endoscopy system represents a risk-of-harm product where injury has not yet been reported, fitting the rubric's Score 3 criteria.
Plain-English summary
Olympus Corporation of the Americas is recalling 45 units of the EVIS EXERA III Video System Center, Model Number CV-190. This medical device is designed to be used with OLYMPUS camera heads, endoscopes, light sources, monitors, and other accessories for endoscopic diagnosis and treatment.
Certain units with specific serial numbers fail to start properly due to power supply components that do not meet specifications. This manufacturing defect prevents the affected devices from operating.
The recalled units have been distributed throughout the United States. Users and healthcare facilities should immediately verify whether they possess any of the affected serial numbers and discontinue use of those devices. Contact Olympus Corporation of the Americas for information regarding replacement or repair options.
The recalled product
- Product
- EVIS EXERA III Video System Center Model Number CV-190. Intended to be used with OLYMPUS camera heads, endoscopes, light sources, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis, treatment, and video observation
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 45
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 (1)
- UDI-DI: 04953170298622
Distribution
Distributed nationwide across the United States.
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