Z-0984-2019Class II

Uroskop Omnia -fluoroscopic X-ray system Model # 10094910 The Uroskop Omnia is a solid state detector...

Name: Z-0984-2019 Uroskop Omnia -fluoroscopic X-ray system Model # 10094910 The Uroskop Omnia is a solid state detector...
Creator: Siemens Medical Solutions USA, Inc
Published: 2019-02-08
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2019-02-08 / Terminated / root cause: design

FDA source

Siemens Medical Solutions USA, Inc began a recall of Uroskop Omnia -fluoroscopic X-ray system Model # 10094910 The Uroskop Omnia is a solid state detector fluoroscopic X-ray system, primarily for urological... on 2019-02-08. FDA classified it as Class II and gives the reason as "The swivel arm holding the monitors may become dislodged from the carrying arm". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0984-2019
Classification: Class II
Status: Terminated
Initiated: 2019-02-08
Posted: 2019-03-07
Terminated: 2020-05-05
Recalling firm: Siemens Medical Solutions USA, Inc.
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).
Product code: JAA System, X-Ray, Fluoroscopic, Image-Intensified
Reason for recall: The swivel arm holding the monitors may become dislodged from the carrying arm.
Root cause tag: design
FDA root cause: Device Design
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.
Quantity in commerce: 6
Distribution: US Nationwide Distribution
Product codes and lots: Serial Numbers: 3414 3415 3416 3417 3418 3428

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0984-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0984-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-13	2019-03-07
Z-0985-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-13	2019-03-07

Product code JAA

K101491Class IIUroskop OmniaSiemens Medical Solutions USA, Inc. / cleared 2010-06-30

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)