Z-0805-2021Class II

Uroskop Omnia, Model no. 10094910 -

Name: Z-0805-2021 Uroskop Omnia, Model no. 10094910 -
Creator: Siemens Medical Solutions USA, Inc
Published: 2020-09-09
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2020-09-09 / Terminated / root cause: design

FDA source

Siemens Medical Solutions USA, Inc began a recall of Uroskop Omnia, Model no. 10094910 - Product Usage: a solid state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray... on 2020-09-09. FDA classified it as Class II and gives the reason as "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". 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-0805-2021
Classification: Class II
Status: Terminated
Initiated: 2020-09-09
Posted: 2021-01-08
Terminated: 2021-04-16
Recalling firm: Siemens Medical Solutions USA, Inc.
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).
Product code: JAA System, X-Ray, Fluoroscopic, Image-Intensified
Reason for recall: 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 tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 6
Distribution: Worldwide distribution.
Product codes and lots: Serial Nos. 3417 3414 3415 3418 3428 3416

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0805-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0805-2021	Class II	Terminated	Voluntary: Firm initiated	2021-01-20	2021-01-08
Z-0806-2021	Class II	Terminated	Voluntary: Firm initiated	2021-01-20	2021-01-08

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)