Siemens Uroskop Omnia Max Recalled for Software Collision and Image Errors
Siemens is recalling 194 Uroskop Omnia Max units due to software issues that may cause system collisions or incorrect diagnostic images.
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 risk of physical collision with persons or obstacles, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 194 units of the SIEMENS Healthineers Uroskop Omnia max (Model: 10762473). The device is intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The recall is due to two software issues affecting the device and related systems.
The first issue involves the override function used when system movements are blocked. Using this function may cause the system, under operator control, to collide with obstacles or persons. The second issue involves incorrectly assigned images on systems with the detector MAX Static, which may cause an incorrect base for diagnosis.
The affected units were distributed nationwide in the US. Siemens is the recalling firm. Consumers and healthcare facilities should check their serial numbers against the list provided in the official recall notice and contact Siemens for further instructions.
The recalled product
- Product
- SIEMENS Healthineers Uroskop Omnia max Model: 10762473 - Product Usage: is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 194
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 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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