—#203683

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

FDA product code: FDF — Colonoscope And Accessories, Flexible/Rigid
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K131780
Affected 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

Why it was 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.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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 Cynthia.Ow@Olympus.com.

Recalling firm

Firm: Olympus Corporation of the Americas
Address: 3500 Corporate Pkwy, Center Valley, Pennsylvania 18034-8229

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2023-09-14
Posted by FDA: 2024-10-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #203683. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.