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Terminated

Uroskop Omnia Max -fluoroscopic X-ray system Model # 10762473 Uroskop Omnia Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image.

FDA Recall Z-0985-2019 · Posted None

Recall StatusTerminated
Product CodeOWB
Date Initiated2019-02-08
Date Terminated2020-05-05
Product Quantity191

Reason for Recall

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

Firm Action

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.

Root Cause

Device Design

Distribution Pattern

US Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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