Olympus ENDOEYE HD II Video Telescopes. Models WA50040A ENDOEYE HD II, 10 mm, 0 degree, WA50042A ENDOEYE HD II 10 mm, 30
FDA device recall Z-0403-2016 · posted 2015-12-10 · Terminated
Recall details
- Recalling firm
- Olympus Corporation of the Americas
- Reason for recall
- A damaged temperature sensor at the ENDOEYE tip caused the distal end to become abnormally hot. Excessive heating of the ENDOEYE distal end could result in patient or user injury.
- Action taken
- Olympus Corporation of Americas sent a letter dated November 25, 2015, to all affected customers to inspect the serial #'s to identify if the affected lots were in inventory and discontinue of the affected lots. Then return all aftected lots for repair and service. Customers were instructed to contact the Customer Care Center at 800-537-5739, Option 2 for instructions on returninng the ENDOEYE for repair and service. The form should be faxed to 484-896-7128. Customers with questions were instructed to call 484-896-5688.
- Root cause
- Unknown/Undetermined by firm
- Status
- Terminated
- Product code
- HET
- Quantity affected
- 182
- Distribution
- US Nationwide Distribution including these states: NE, IL, FL, TX, OH, PA, IN, CA, NY, AL, ND, GA, AK, MI, WA, MS, NJ, IA, AZ, and RI.
- Date initiated
- 2015-11-17
- Date posted
- 2015-12-10
- Date terminated
- 2017-01-24
- Location
- Center Valley, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ENDOEYE HD II (K111788) | Olympus America, Inc. | 2012-01-13 |