Z-0056-2025Class II

EVIS EXERA III Video System Center Model Number CV-190. Intended to be used with OLYMPUS camera heads...

Name: Z-0056-2025 EVIS EXERA III Video System Center Model Number CV-190. Intended to be used with OLYMPUS camera heads...
Creator: Olympus Corporation of the Americas
Published: 2023-09-14
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2023-09-14 / Open, Classified / root cause: manufacturing process

FDA source

Olympus Corporation of the Americas began a recall of EVIS EXERA III Video System Center Model Number CV-190. Intended to be used with OLYMPUS camera heads, endoscopes, light sources, monitors, EndoTherapy... on 2023-09-14. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0056-2025
Classification: Class II
Status: Open, Classified
Initiated: 2023-09-14
Posted: 2024-10-11
Recalling firm: OLYMPUS Corporation of the Americas
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
Product code: FDF Colonoscope And Accessories, Flexible/Rigid
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: An URGENT: MEDICAL DEVICE FIELD CORRECTIVE ACTION notification letter dated 9/14/23 was sent to customers. Action steps to be taken by the end user: Olympus has determined based upon our distribution records that your facility is in possession of one or more affected CV-190 with a serial number shown in Attachment 1. Olympus requires that you take the following actions: 1. Inspect your inventory for the referenced products and identify any devices with the model number and serial number specified in Attachment 1. Cease use of products and quarantine any affected products. Please check all areas of the hospital to determine if any of these products remain in inventory. 2. Please contact our Olympus Repair Center at 1-800-848-9024, option 3, to arrange for a service to exchange the power supply unit in affected devices. Olympus regrets any inconvenience caused and fully appreciates your prompt cooperation in addressing this situation. If you require additional information, please do not hesitate to contact me at 647-999-3203 or [email protected].
Quantity in commerce: 45 units
Distribution: US Nationwide distribution.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0056-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0056-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-23	2024-10-11

Product code FDF

K131780Class IIEvis Exera III Video SystemOlympus Medical Systems Corp. / cleared 2013-08-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)