EasySuite 4K Integrated Operating Room System Model/Catalog Number: EasySuite 4K- The EasySuite 4K system includes a tou

FDA device recall Z-2233-2024 · posted 2024-06-28 · Open, Classified

Recall details

Recalling firm

Olympus Corporation of the Americas

Reason for recall

A subset of the ES4K systems do not have complete records for earth leakage testing. The earth leakage test is a series of measurements intended to confirm that the amount of electrical current flowing to the earth is within standard limits

Action taken

Olympus issued Urgent: Medical Device Corrective Action letter on May 24, 2024 via Courier, 2-day delivery. Letter states reason for recall, health risk and action to take: An Olympus representative will reach out to you to schedule an on-site service to perform the earth leakage testing on your facility s ES4K system. You may continue to use your ES4K system until an Olympus representative performs the earth leakage test. Additionally, Olympus requires you to take the following actions: 1. Carefully read the content of this notification. 2. If you have further distributed this product, identify your customers, and forward them this notification. 3. Acknowledge receipt of this letter through our Olympus recall portal: a. Go to https://olympusamerica.com/recall. b. Enter the recall number "0446 c. Complete the form as instructed and include your account ID number. 4. An Olympus representative will contact you to complete the earth leakage test which will serve as the completion of this field corrective action for your facility. Olympus requests that you report any complaints, including surgical displays becoming inoperable/unusable or touch current sensation (i.e., vibration, slight tingle), to the Technical Assistance Center (TAC) at 1- 800-848-9024, option 1.

Root cause

Process control

Status

Open, Classified

Product code

NAY

Quantity affected

227 units

Distribution

Worldwide distribution - US Nationwide and the countries of Germany, Hong Kong.

Date initiated

2024-04-24

Date posted

2024-06-28

Location

Center Valley, PA