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U.S. Department of Health and Human Services

Class 2 Device Recall EVIS EXERA System

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 Class 2 Device Recall EVIS EXERA Systemsee related information
Date Initiated by FirmApril 22, 2022
Create DateJune 21, 2022
Recall Status1 Terminated 3 on March 13, 2024
Recall NumberZ-1274-2022
Recall Event ID 90218
510(K)NumberK100584 
Product Classification Colonoscope and accessories, flexible/rigid - Product Code FDF
ProductColonovideoscope Model CF-H180AL
Code Information UDI-DI: 04953170339615 Serial number: 2501131
FEI Number 2429304
Recalling Firm/
Manufacturer		 Olympus Corporation of the Americas
3500 Corporate Pkwy
Center Valley PA 18034-8229
For Additional Information ContactSAME
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
ActionOlympus 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 Commerce1 unit
DistributionUS Nationwide distribution in the state of KY.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = FDF
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