Date Initiated by Firm |
April 22, 2022 |
Create Date |
June 21, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1275-2022 |
Recall Event ID |
90232 |
Product Classification |
Gastroscope and accessories, flexible/rigid - Product Code FDS
|
Product |
EVIS EXERA II Gastrointestinal Videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model: GIF-HQ190
|
Code Information |
UDI-DI: 04953170305276
Serial: 2269931, 2611873, 2613235, 2634251, 2634326, 2860721, 2961773 and 2962545
|
Recalling Firm/ Manufacturer |
Olympus Corporation of the Americas 3500 Corporate Pkwy Center Valley PA 18034-8229
|
For Additional Information Contact |
SAME 484-896-5000
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Manufacturer Reason for Recall |
Part (A-rubber) intended for a different model of gastrointestinal videoscope may have been used when
replacing part on GIF-HQ190 during the last repair at Olympus. An Incorrect A-rubber fits tighter on the GIF-HQ190 which would not meet the intended design specifications
|
FDA Determined Cause 2 |
Nonconforming Material/Component |
Action |
Olympus issued Urgent Medical Device Correction letter via email on 4/22/22. 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 for a service loaner in an effort to not disrupt patient care.
Please do not hesitate to contact @ 647-999-3203 or at Cynthia.Ow@Olympus.com for any additional information or support concerning this matter. |
Quantity in Commerce |
8 units |
Distribution |
US Nationwide distribution in the states of AL, FL, NC, NY.
|
Total Product Life Cycle |
TPLC Device Report
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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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