Agency classClass IIOur severity:Severe FDA (Devices)·Z-1333-2020·Announced 2020-02-26

Siemens Uroskop Omnia max Recalled for Collision Control Override Risk

Siemens is recalling 192 Uroskop Omnia max devices because a bypass key can override collision controls, creating a risk of collision with obstacles or persons.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk of collision with persons, which aligns with the rubric criterion for significant injury reports or high-risk physical hazards.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 192 units of the Uroskop Omnia max, Model No. 10762473. This medical device is intended to visualize anatomical structures by converting an X-ray pattern into a visible image, primarily for urological diagnosis and therapeutic applications.

The recall is due to an issue where the incorrect use of the bypass key can override the built-in collision control. This creates a risk of collision with obstacles or persons when the operator uses the override function. The affected units were distributed nationwide in the United States.

Healthcare facilities should identify affected units by checking the serial numbers listed in the official recall notice. Siemens is the recalling firm for this Class II recall.

The recalled product

Product: Uroskop Omnia max, Model No. 10762473 - Product Usage: Uroskop Omnia Max is a device intended to visualize anatomical structures by converting an Xray pattern into a visible image. The system is designed primarily for urological diagnosis and the support of urological…
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — Imaging Equipment
Hazard: collision
physical-injury
Affected units: 192

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 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.

See all 3 products in this recall →

Same manufacturer · Siemens Medical Solutions USA, Inc

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