| Class 2 Device Recall Olympus ENDOEYE HD II Video Telescopes | |
Date Initiated by Firm | February 10, 2017 |
Date Posted | February 21, 2017 |
Recall Status1 |
Terminated 3 on May 09, 2018 |
Recall Number | Z-1929-2017 |
Recall Event ID |
76488 |
510(K)Number | K111788 |
Product Classification |
Laparoscope, gynecologic (and accessories) - Product Code HET
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Product | Olympus ENDOEYE HD II Video Telescopes
Models:
WA50040A Endoeye HD II, 10 mm, 0 deg., autoclavable;
WA50042A Endoeye HD II, 10 mm, 30 deg., autoclavable;
repair cable 10mm 0/30 deg., part number W7100603 |
Code Information |
All serial numbers |
Recalling Firm/ Manufacturer |
Olympus Corporation of the Americas 3500 Corporate Pkwy PO Box 610 Center Valley PA 18034-0610
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For Additional Information Contact | Laura Storms 484-896-5688 |
Manufacturer Reason for Recall | A damaged temperature sensor at the endoscope's tip can cause the endoscope's distal end to become abnormally hot. |
FDA Determined Cause 2 | Device Design |
Action | A letter to consignees was sent February 10, 2017. Olympus will be repairing the device at user sites by disabling the temperature sensor. |
Quantity in Commerce | 863 units |
Distribution | Nationwide |
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = HET
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