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U.S. Department of Health and Human Services

Class 2 Device Recall EVIS EXERA III

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 Class 2 Device Recall EVIS EXERA IIIsee related information
Date Initiated by FirmSeptember 14, 2023
Date PostedOctober 11, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0056-2025
Recall Event ID 93217
510(K)NumberK131780 
Product Classification Colonoscope and accessories, flexible/rigid - Product Code FDF
ProductEVIS 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
Code Information 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
FEI Number 2429304
Recalling Firm/
Manufacturer		 Olympus Corporation of the Americas
3500 Corporate Pkwy
Center Valley PA 18034-8229
For Additional Information ContactCynthia Ow
647-999-3203
Manufacturer 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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionAn 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.
Quantity in Commerce45 units
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = FDF
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