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SOLTIVE recallZ-2504-2024 · Olympus Corporation of the Americas · initiated May 31, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Olympus Corporation of the Americas or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure.

FDA root cause category: Device Design

What the company is doing

On 06/28/2024 URGENT MEDICAL DEVICE CORRECTION letters were sent to customers. Actions Required: Our records indicate that your facility has purchased one or more of these products. Therefore, Olympus requires you to take the following actions: 1. Carefully read the content of this notification. 2. Inspect your inventory and identify any devices with the model names specified above. Please check all areas of the hospital to determine if any of these devices remain in inventory. 3. Ensure all personnel are completely knowledgeable and thoroughly trained on the content of this notification and the Soltive Laser System Instructions for Use, including instructions related to connecting the wireless footswitch. 4. Olympus requests that you acknowledge receipt of this letter. Access the Olympus recall portal to indicate that you have received this notification. a. Go to https://olympusamerica.com/recall b. Enter the recall number "0448 c. Complete the form as instructed and include your account ID number. d. Indicate in the comments if your facility does not have a wired footswitch. Olympus Customer Service will contact you to make arrangements for a wired footswitch. 5. If you have further distributed this product, identify your customers, and forward them this notification. Olympus requests that you report any complaints, including failure of the wireless footswitch pairing with the Soltive Laser System, or any associated injuries to the Technical Assistance Center (TAC) at 1- 800-848-9024, option 1, and the FDA. Adverse events experienced with the use of this product may also be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax. Olympus fully appreciates your prompt cooperation. If you require additional information, please do not hesitate to contact me directly by phone at (647) 999-3203 from Monday through Friday or by e-mail [email protected].

Recall details

Recall number
Z-2504-2024
Status
Open, Classified
Initiated by the company
May 31, 2024
Posted by the FDA
Aug 5, 2024
Recalling firm
Olympus Corporation of the Americas
Quantity
1,585 Units
Product code
GEX
FDA submissions
K221306
Distribution
Worldwide distribution - US Nationwide and the countries of Australia, Canada, Chile, Germany, Hong Kong, Japan, Singapore.

Product description

Soltive Premium SuperPulsed Laser System, Model TFL-PLS

Code information (models, lots, serial numbers)

Model: TFL-PLS; UDI-DI: 00821925044111; Serial Numbers: All Serial Numbers.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 94964).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page