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

FDA device recall Z-0056-2025 · posted 2024-10-11 · Open, Classified

Recall details

Recalling firm

Olympus Corporation of the Americas

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.

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Open, Classified

Product code

FDF

Quantity affected

45 units

Distribution

US Nationwide distribution.

Date initiated

2023-09-14

Date posted

2024-10-11

Location

Center Valley, PA

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