FDAClass IIMarch 13, 2019

Uroskop Omnia -fluoroscopic X-ray system recall

Uroskop Omnia -fluoroscopic X-ray system Model # 10094910 The Uroskop Omnia is a solid state detector fluoroscopic X-ray system, primarily for…

Why was Uroskop Omnia -fluoroscopic X-ray system recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Serial Numbers: 3414 3415 3416 3417 3418 3428

Product
Uroskop Omnia -fluoroscopic X-ray system Model # 10094910 The Uroskop Omnia is a solid state detector fluoroscopic X-ray system, primarily for…
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
6
Distribution
US Nationwide Distribution
Recall date
March 13, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls