Siemens Uroskop Omnia Fluoroscopic X-ray System Recalled for Monitor Arm Defect
Siemens is recalling six Uroskop Omnia fluoroscopic X-ray systems because the swivel arm holding the monitors may become dislodged from the carrying arm.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a structural defect in a medical device that could result in falling equipment, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling six units of the Uroskop Omnia fluoroscopic X-ray system, Model # 10094910. The affected units are identified by serial numbers 3414, 3415, 3416, 3417, 3418, and 3428. The Uroskop Omnia is a solid state detector fluoroscopic X-ray system primarily used for urological applications, including functional x-ray diagnosis, endourology, and minimal invasive urology/surgery.
The recall was initiated because the swivel arm holding the monitors may become dislodged from the carrying arm. This defect presents a risk of the monitors falling. The affected units were distributed nationwide in the United States.
Healthcare facilities and users of these specific serial numbers should stop using the affected equipment and contact Siemens Medical Solutions USA, Inc. for further instructions on repair or replacement.
The recalled product
- 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).
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- Affected units
- 6
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Serial Numbers: 3414 3415 3416 3417 3418 3428
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Siemens Medical Solutions USA, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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