Soltive Premium Super Pulsed Laser System recall
Soltive Premium Super Pulsed Laser System (TFL-PLS) & Pro Super Pulsed Laser System (TFL-SLS). Intended for incision, excision, resection, ablation…
Why was Soltive Premium Super Pulsed Laser System recalled?
Thermal injury following dusting and fragmenting treatment of ureteral stones when user exceeded the 20W standard presets
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Software Version 2.0 (all serial numbers)
- Product
- Soltive Premium Super Pulsed Laser System (TFL-PLS) & Pro Super Pulsed Laser System (TFL-SLS). Intended for incision, excision, resection, ablation…
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 408 units
- Distribution
- US Nationwide Distribution Foreign: Canada Australia Japan Hong Kong Europe Singapore
- Recall date
- August 25, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)