Skip to content

OES 4000 Hysteroscope, Model/Catalog Number: A4674A recallZ-2029-2024 · Olympus Corporation of the Americas · initiated Apr 18, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Olympus Corporation of the Americas or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Process change control

What the company is doing

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 [email protected]

Recall details

Recall number
Z-2029-2024
Status
Open, Classified
Initiated by the company
Apr 18, 2024
Posted by the FDA
Jun 6, 2024
Recalling firm
Olympus Corporation of the Americas
Quantity
1 unit
Product code
HIH
FDA submissions
K897003
Distribution
US Nationwide distribution in the state of NY.

Product description

OES 4000 Hysteroscope, Model/Catalog Number: A4674A

Code information (models, lots, serial numbers)

Model/Catalog Number: A4674A, UDI-DI: 04042761006361, Serial Number: 805904;

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

5 devices cleared under K897003 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page