FDAClass IIOctober 23, 2024

EVIS EXERA III Video System Center recall

EVIS EXERA III Video System Center Model Number CV-190. Intended to be used with OLYMPUS camera heads, endoscopes, light sources, monitors…

Why was EVIS EXERA III Video System Center recalled?

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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
EVIS EXERA III Video System Center Model Number CV-190. Intended to be used with OLYMPUS camera heads, endoscopes, light sources, monitors…
Recalling firm
Olympus Corporation of the Americas
Quantity
45 units
Distribution
US Nationwide distribution.
Recall date
October 23, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls