Recall Z-1385-2024 ยท GEX Powered Laser Surgical Instrument
Olympus Corporation of the Americas
SOLTIVE Premium SuperPulsed Laser (TFL-PLS )
| Date | Mar 27, 2024 (initiated Jan 29, 2024) |
| Status | Open, Classified |
| Reason | A non-compliant power cord may have been supplied in regions that do not utilize the Type B or Type E/F plug configurations. |
| Root cause | Under Investigation by firm |
| Action | On February 21, 2024, the firm notified customers of the issue via MEDICAL DEVICE CORRECTION letters. Actions to be taken by the customer: 1. Ensure all personnel, including clinical staff, are completely knowledgeable and thoroughly aware of the contents of this letter. 2. Access the Olympus recall portal to indicate that you have received this notification. Go to https://olympusamerica.com/recall. Enter the recall number and provide your contact information as indicated in the portal. 3. Confirm that the installed power cord meets the specifications detailed in this letter via your Biomedica |
| Quantity | 203 Units (OUS Only) |
| Distribution | Domestic: OUS Only; International distribution in the states of Australia, Chile, Germany, Hong Kong, Japan, New Zealand and Singapore. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K221306 | SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and Accessories Gyrus Acmi, Inc., Jan 27, 2023 |