Z-2294-2021Class II

Soltive Premium Super Pulsed Laser System (TFL-PLS) & Pro Super Pulsed Laser System (TFL-SLS). Intended for...

Name: Z-2294-2021 Soltive Premium Super Pulsed Laser System (TFL-PLS) & Pro Super Pulsed Laser System (TFL-SLS). Intended for...
Creator: Olympus Corporation of the Americas
Published: 2021-06-30
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2021-06-30 / Terminated / root cause: software

FDA source

Olympus Corporation of the Americas began a recall of Soltive Premium Super Pulsed Laser System (TFL-PLS) & Pro Super Pulsed Laser System (TFL-SLS). Intended for incision, excision, resection, ablation... on 2021-06-30. FDA classified it as Class II and gives the reason as "Thermal injury following dusting and fragmenting treatment of ureteral stones when user exceeded the 20W standard presets". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2294-2021
Classification: Class II
Status: Terminated
Initiated: 2021-06-30
Posted: 2021-08-15
Terminated: 2024-01-26
Recalling firm: OLYMPUS Corporation of the Americas
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, gastroenterological surgery and gynecological surgery
Product code: GEX Powered Laser Surgical Instrument
Reason for recall: Thermal injury following dusting and fragmenting treatment of ureteral stones when user exceeded the 20W standard presets
Root cause tag: software
FDA root cause: Software design
Action: Olympus issued Urgent Medical Device Correction on June 30, 2021 via Federal Express Second Day Delivery. Letter states reason for recall, health risk and action to take: To mitigate and prevent thermal injury events, Olympus is issuing a software upgrade for the Soltive Laser to version 2.1. Software version 2.1 includes a new Ureteral Stone Preset of 8W under the Lithotripsy treatment mode. The Soltive Laser Instructions for Use (IFU) has been updated to reflect these software changes which also includes a pop-up alert reminding user to consider the potential clinical consequences of selecting settings greater than 20W in sensitive anatomy like the ureter. Enclosed with this letter is an addendum to the IFU containing a summary of the new updated IFU sections. Action Steps: 1. Starting June 2021 an Olympus representative will reach out to you to arrange a mutually convenient time to have your product(s) updated. 2. Access the Olympus recall portal to indicate that you have received this notification. Go to https://olympusamerica.com/recall. Enter the recall number Recall-0XXX and provide your contact information as indicated in the portal. 3. If you have distributed these devices outside your facility, please notify your customers of this corrective action immediately. Your notification to your customers may be enhanced by including a copy of this recall notification letter. Olympus regrets any inconvenience from this corrective action and fully appreciates your prompt cooperation in addressing this situation. Please do not hesitate to contact me directly at at [email protected] for any additional information concerning this matter.
Quantity in commerce: 408 units
Distribution: US Nationwide Distribution Foreign: Canada Australia Japan Hong Kong Europe Singapore
Product codes and lots: Software Version 2.0 (all serial numbers)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2294-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2294-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-25	2021-08-15

Product code GEX

K211401Class IISOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)Gyrus Acmi, Inc. / cleared 2021-06-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)