Thunderbeat pistol grip devices removed after continued adverse event reports
Olympus is removing the Olympus Thunderbeat, 5 mm, 45 cm, Pistol Grip from the market, stating the action is due to continued reports of adverse events.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: the firm is removing the device because of continued reports of adverse events, though the record does not describe them or report injuries.
Plain-English summary
The Olympus Thunderbeat, 5 mm, 45 cm, Pistol Grip, model number TB-0545PC, is being recalled by Olympus Corporation of the Americas.
The reason given in the enforcement record is that the firm is initiating a removal due to continued reports of adverse events. The record does not describe the adverse events, so none are set out here.
The record lists 30 units under UDI 04953170308635, covering all lots. Distribution was worldwide, covering the United States nationwide and Brazil, Canada, Germany, Mexico and other countries listed in the record. The FDA has classified the action as Class II.
Facilities should stop using the affected devices and follow Olympus' instructions.
The recalled product
- Product
- Olympus Thunderbeat, 5 mm, 45 cm, Pistol Grip
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 30
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model No. TB-0545PC
- UDI: 04953170308635
- All Lots.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 recalled by Olympus Corporation of the Americas under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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