—#184973

Product

Uroskop Omnia, Model no. 10094910 - Product Usage: a solid state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray diagnosis, endourology and minimal invasive urology/surgery).

FDA product code: JAA — System, X-Ray, Fluoroscopic, Image-Intensified
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K101491
Affected lot / code info: Serial Nos. 3417 3414 3415 3418 3428 3416

Why it was recalled

After the March 2019 corrective action on the monitor support arm, there is a residual risk of the support arm becoming dislodged in cases when the monitor support arm is used intensely over a long period of time.

Root cause (FDA determination)

Device Design

Action the firm took

On September 9, 2020, the firm distributed Urgent Medical Device Correction letters to affected customers. Customers were informed that the firm has released an additional safety measure to avoid the potential issue. A safety gear will be installed into the monitor support arm out of an abundance of caution. The corrective action is available and is being provided to affected users free of charge. The firm will contact customers to arrange a date to perform the corrective action. Please feel free to contact the firm to schedule an earlier appointment at 1-800-888-7436.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 40 Liberty Blvd, Malvern, Pennsylvania 19355

Distribution

Distribution pattern: Worldwide distribution.

Timeline

Recall initiated: 2020-09-09
Terminated: 2021-04-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #184973. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.