Date Initiated by Firm |
April 22, 2022 |
Create Date |
June 21, 2022 |
Recall Status1 |
Terminated 3 on March 13, 2024 |
Recall Number |
Z-1274-2022 |
Recall Event ID |
90218 |
510(K)Number |
K100584
|
Product Classification |
Colonoscope and accessories, flexible/rigid - Product Code FDF
|
Product |
Colonovideoscope Model CF-H180AL |
Code Information |
UDI-DI: 04953170339615
Serial number: 2501131 |
Recalling Firm/ Manufacturer |
Olympus Corporation of the Americas 3500 Corporate Pkwy Center Valley PA 18034-8229
|
For Additional Information Contact |
SAME 484-896-5000
|
Manufacturer Reason for Recall |
A (Camera unit) CCD intended for a different model of colonoscope may have been installed in the CF-H180AL, viewing angle would be narrower than a normal CF-H180AL and the use of EndoTherapy devices may stick out (approximately 1.4 mm) further than normal protrusion,could lead to patient injury; specifically, mucosal damage that could result in hemorrhage or bleeding
|
FDA Determined Cause 2 |
Nonconforming Material/Component |
Action |
Olympus issued letter via e-mail on April 22, 2022. Letter states reason for recall, health risk and action to take:
1. Identify the affected model and serial number in the subject of this letter.
2. An Olympus representative will contact you to arrange for the return of your affected device. Olympus will repair your unit free of charge.
3. Olympus will provide a service loaner device in an effort to not disrupt patient care.
Contact: 647-999-3203 or at Cynthia.Ow@Olympus.com |
Quantity in Commerce |
1 unit |
Distribution |
US Nationwide distribution in the state of KY. |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = FDF and Original Applicant = OLYMPUS MEDICAL SYSTEMS CORPORATION
|