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U.S. Department of Health and Human Services

Class 2 Device Recall EVIS EXERA III Gastrointestinal Videoscope

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 Class 2 Device Recall EVIS EXERA III Gastrointestinal Videoscopesee related information
Date Initiated by FirmOctober 02, 2023
Date PostedNovember 09, 2023
Recall Status1 Open3, Classified
Recall NumberZ-0288-2024
Recall Event ID 93212
510(K)NumberK112680 
Product Classification Colonoscope and accessories, flexible/rigid - Product Code FDF
ProductEVIS EXERA III Gastrointestinal Videoscope
Code Information Model No. GIF-1TH190; UDI-DI: 04953170343360; All Serial Numbers.
Recalling Firm/
Manufacturer		 Olympus Corporation of the Americas
3500 Corporate Pkwy
Center Valley PA 18034-8229
For Additional Information ContactCynthia Ow
647-999-3203
Manufacturer Reason
for Recall		Sterilization failures when devices are sterilized per the Reprocessing Manual due to lack of drying time for the endoscope channel.
FDA Determined
Cause 2		Reprocessing Controls
ActionThe firm distributed recall notifications via mail to consignees dated 10/02/2023. Consignees are asked to inspect inventory for affected devices, ensure that all reprocessing personnel are aware and knowledgeable of the recall notice and its contents, and acknowledge receipt of the recall notification by returning the enclosed response form via email to olympus5381@sedgwick.com or by fax at 800-913-4345. Customers with any questions about the acknowledgement form are to call 866-912-9544. Customers with any questions about the recall are to contact Cynthia Ow by phone at 647-999-3203 or by email at Cynthia.Ow@Olympus.com.
Quantity in Commerce1687 units
DistributionNationwide Distribution.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = FDF
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