EVIS EXERA III Video System Center Model Number CV-190. Intended to be used with OLYMPUS camera heads, endoscopes, light
Summary
The FDA issued a Class II for EVIS EXERA III Video System Center Model Number CV-190. Intended to be used with by Olympus Corporation of the Americas. Reason: Certain serial numbers of the CV-190 do not start up properly because parts that deviated from the specification were assembled into the power supply .
Details
Source
Device Recall
External ID
Z-0056-2025
Action Date
2024-10-23
Status
Ongoing
Category
device
Product Description
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
Lot/Code Info: UDI-DI: 04953170298622; Serial Numbers: 7384484 7384422 7384487 7384478 7384479 7384442 7384441 7384485 7384451 7384455 7384481 7384470 7384424 7384423 7384489 7384531 7384516 7384492 7384512 7384543 7384483 7384624 7384623 7384497 7384495 7384494 7384533 7384622 7384660 7384654 7384656 7384647 7384658 7384675 7384655 7384704 7384709 7384687 7384706 7384661 7384662 7384703 7384670 7384679 7384678
Quantity Affected: 45 units
Reason for Recall
Certain serial numbers of the CV-190 do not start up properly because parts that deviated from the specification were assembled into the power supply unit.
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-09-14
Company
Center Valley, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 180 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Olympus Corporation of the Americas has 334 FDA actions in our database, including 334 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Olympus Corporation of the Americas) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Olympus Corporation of the Americas have FDA actions?
Olympus Corporation of the Americas has 334 FDA actions in our database, including 334 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0056-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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