OES 4000 Hysteroscope, Model/Catalog Number: A4674A
This recall is currently active, issued June 6, 2024. It was issued by Olympus Corporation Of The Americas.
- Recall Initiated
- April 18, 2024
- Posted
- June 6, 2024
- Recall Number
- Z-2029-2024
- Quantity
- 1 unit
- Firm Location
- Center Valley, PA
- Official Source
- View on FDA website ↗
Reason for Recall
The required leakage test was not performed following of a re-work for a non-conformity. This could potentially result in liquid ingress into the eyepiece and cause a foggy image.
Distribution
US Nationwide distribution in the state of NY.
Lot / Code Info
Model/Catalog Number: A4674A, UDI-DI: 04042761006361, Serial Number: 805904;
Root Cause
Process change control
Action Taken
On May 9, 2024, URGENT: MEDICAL DEVICE REMOVAL letters were sent to the consignee. Actions Required: Our records indicate that your facility has purchased one or more of the affected products. Therefore, Olympus requires you to take the following actions: 1. Carefully read the content of this notification. 2. Examine your inventory and identify the above listed device with serial number. 3. Please contact Customer Service at at 1-800-848-9024, option 2, to obtain a Return Material Authorization. Olympus will arrange for the return of your device to Olympus, and we will replace this device at no charge. 4. Olympus requests that you acknowledge receipt of this letter through the a. Go to https://olympusamerica.com/recall b. Enter the recall number "XXXX . c. Complete the form as instructed and include your account ID number: XXXXXXXX 5. If you have further distributed this product, identify your customers, and forward them this notification. Olympus requests that you report any complaints, including foggy image, to the Technical Assistance Center (TAC) at 1- 800-848-9024, option 1, and the FDA. Adverse events experienced with the use of this product may also be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax. Olympus fully appreciates your prompt cooperation in addressing this situation. If you require additional information, please do not hesitate to contact me directly by phone at (647) 999-3203 or by e-mail at Cynthia.Ow@olympus.com