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U.S. Department of Health and Human Services

Class 2 Device Recall Olympus

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  Class 2 Device Recall Olympus see related information
Date Initiated by Firm September 25, 2023
Date Posted November 17, 2023
Recall Status1 Open3, Classified
Recall Number Z-0329-2024
Recall Event ID 93222
Product Classification Endoscopic video imaging system/component, gastroenterology-urology - Product Code FET
Product Colonoscope: for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve).

Models:
CF-2T160I
CF-2T160L
CF-H170I
CF-H170L
CF-H180AI
CF-H180AL
CF-H180DI
CF-H180DL
CF-H190I
CF-H190L
CF-HQ190I
CF-HQ190L
CF-LV1I
CF-LV1L
CF-Q150I
CF-Q150L
CF-Q160S
CF-Q180AI
CF-Q180AL
Code Information UDI-DI: CF-2T160I 04953170307645 CF-2T160L 04953170307652 CF-H170I 04953170334184 CF-H170L 04953170334160 CF-H180AI 04953170339585 CF-H180AL 04953170339608 CF-H180DI 04953170339639 CF-H180DL 04953170339653 CF-H190I 04953170305177 CF-H190L 04953170305153 CF-HQ190I 04953170305139 CF-HQ190L 04953170305115 CF-LV1I 04953170312410 CF-LV1L 04953170312397 CF-Q150I 04953170307621 CF-Q150L 04953170307638 CF-Q160S 04953170307669 CF-Q180AI 04953170307690 CF-Q180AL 04953170307706
Recalling Firm/
Manufacturer		 Aizu Olympus Co., Ltd.
3 Chome 1-1
Niiderakita
Aizuwakamatsu Japan
For Additional Information Contact SAME
242-282111
Manufacturer Reason
for Recall		 Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
FDA Determined
Cause 2		 Under Investigation by firm
Action Olympus America issued Urgent Medical Device Correction letter on Sept. 25, 2023 to Endoscopy, Respiratory, Pulmonary and Urology Departments, Risk Management Department. Letter states reason for recall, health risk and action to take: Our records indicate that Olympus has serviced your flexible endoscope at one of our Olympus repair facilities. Following repair activities, Olympus uses a water flush of endoscope channels as part of our final endoscope channel inspection, and we subsequently dry the endoscope channels with compressed filtered air. Olympus discovered that our channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Olympus is in the process of implementing a validated drying process at our repair centers. In the meantime, Olympus has established interim processes to perform an additional inspection of your scope for water prior to return. 1. Ensure your users are knowledgeable on the content of this letter. 2. Complete the enclosed response form and return it to our recall partner, Sedgwick, via e-mail at olympus2806@sedgwick.com or by fax at 844-294-7184. For any questions about the acknowledgement form, please call the Sedgwick team at 888-667-1504. 3. Olympus requests that you report complaints, including infections, and endoscopes returned wet from our repair centers to Olympus. Please report complaints to Technical Assistance Center (TAC) at 1-800-848-9024, option 1. Adverse events experienced with the use of this product may also be reported to the Food and Drug Administration MedWatch Adverse Event Reporting program either online, by regular mail or by fax. If you require additional information, please do not hesitate to contact me at (647) 999-3203 or Cynthia.Ow@Olympus.com.
Quantity in Commerce 3344 units
Distribution Worldwide - US Nationwide distribution.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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