OES 4000 Hysteroscope, Model/Catalog Number: A4674A
FDA device recall Z-2029-2024 · posted 2024-06-06 · Open, Classified
Recall details
- Recalling firm
- Olympus Corporation of the Americas
- 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.
- 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
- Root cause
- Process change control
- Status
- Open, Classified
- Product code
- HIH
- Quantity affected
- 1 unit
- Distribution
- US Nationwide distribution in the state of NY.
- Date initiated
- 2024-04-18
- Date posted
- 2024-06-06
- Location
- Center Valley, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OLYMPUS HYSTERORESECTOSCOPE (K897003) | Olympus Corp. | 1990-03-16 |