Visera Hysterovideoscope Olympus HYF Type V
FDA device recall Z-2480-2023 · posted 2023-08-29 · Open, Classified
Recall details
- Recalling firm
- Olympus Corporation of the Americas
- Reason for recall
- IFU labeling is being updated to revise EtO gas mixture and elimination of reusable cleaning brushes.
- Action taken
- A customer letter was issued on July 20, 2023. Customers were advised that the Instructions for use were updated. Customers are asked to complete a response form of acknowledgement and submit to Sedgwick at olympus8606@sedgwick.com or Fax 866-557-1242.
- Root cause
- Reprocessing Controls
- Status
- Open, Classified
- Product code
- HIH
- Quantity affected
- 363 units
- Distribution
- US Nationwide distribution including in the states of AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TX, UT, WA, and WI.
- Date initiated
- 2023-07-20
- Date posted
- 2023-08-29
- Location
- Center Valley, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Visera Hysterovideoscope Olympus HYF Type V (K221557) | Olympus Medical Systems Corporation | 2022-09-02 |
| VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE V (K022445) | Olympus Optical Co., Ltd. | 2003-01-24 |