Device product
Olympus Thunderbeat, 5mm, 35 cm, Pistol Grip
Z-1378-2026
Product summary
- Event
- Event 98188
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3,381 units
- Official record key
device-enforcement:Z-1378-2026
Official wording
Reason: Firm is initiating a removal due to continued reports of adverse events.
Code information: Model No. TB-0535PC; UDI: 04953170308659; All Lots.
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Germany, Mexico, and Japan.
Derived failure modes
-
Unknown
Firm is initiating a removal due to continued reports of adverse events.