—#171135

Product

Uroskop Omnia -fluoroscopic X-ray system Model # 10094910 The Uroskop Omnia is 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 Numbers: 3414 3415 3416 3417 3418 3428

Why it was recalled

The swivel arm holding the monitors may become dislodged from the carrying arm.

Root cause (FDA determination)

Device Design

Action the firm took

The firm, Siemens, issued an "URGENT: MEDICAL DEVICE CORRECTION "on 2/8/19 to its customers. The letter is identifying the problem, risk, actions to take and corrective action. The customers were instructed to do the following: Immediately examine your inventory and quarantine product subject to recall (if applicable). or To avoid the risk until implementation of the corrective action, it is strongly recommended not to move and position monitors above the system table. As an alternative and if clinically applicable, monitors can also be used when they are left in the parking position. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. If the device has been sold and is therefore no longer in your possession, please forward this notice to the new owner. The service organization will contact and arrange a date to perform this corrective action with Updated Instruction XP006/19/S. Contact the service organization for an earlier appointment at 1-800-888-7436.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418

Distribution

Distribution pattern: US Nationwide Distribution

Timeline

Recall initiated: 2019-02-08
Terminated: 2020-05-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #171135. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.