Agency classClass IIOur severity:High FDA (Devices)·Z-2294-2021·Announced 2021-08-25

Soltive Laser Systems recalled for thermal burn injury risk during stone treatment

Olympus is recalling Soltive laser systems used in urological surgery because exceeding recommended power settings can cause thermal burns to tissue during kidney stone treatment.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: This is an FDA Class II medical device recall involving risk of thermal burn injury from exceeding recommended power settings. No reported injuries are documented in the source; however, the hazard presents a documented risk to patients during stone treatment procedures, consistent with severity score 3 for risk-of-harm products without reported injury.

Plain-English summary

Olympus Corporation of the Americas is recalling the Soltive Premium Super Pulsed Laser System (TFL-PLS) and Pro Super Pulsed Laser System (TFL-SLS). These laser systems are used in surgical procedures including urology, lithotripsy, gastroenterological surgery, and gynecological surgery. A total of 408 units have been distributed.

The systems can cause thermal injury to tissue when operators exceed the 20-watt standard power settings during ureteral stone treatment procedures. The thermal injury risk applies specifically to dusting and fragmentation treatment of kidney stones.

The devices have been distributed nationwide in the United States as well as to Canada, Australia, Japan, Hong Kong, Europe, and Singapore. All affected systems operate on Software Version 2.0.

The recall addresses a risk of thermal injury from improper power settings. Healthcare facilities and providers should contact Olympus Corporation of the Americas for information regarding the recall.

The recalled product

Product: Soltive Premium Super Pulsed Laser System (TFL-PLS) & Pro Super Pulsed Laser System (TFL-SLS). Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in urology, lithotripsy…
Manufacturer: Olympus Corporation of the Americas
Category: Medical Device — Surgical Laser
Hazard: thermal-burn-injury
Affected units: 408

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 (1)

Software Version 2.0 (all serial numbers)

Distribution

Distributed nationwide across the United States.

Same manufacturer · Olympus Corporation of the Americas

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