Reported Feb 26, 2020 · Terminated

Uroskop Omnia max, Model No. 10762473 - Product Usage: Uroskop Omnia Max is a device intended to visualize anatomical…

Siemens Medical Solutions USA, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Siemens Medical Solutions USA, Inc · 40 Liberty Blvd · Malvern, PA · 19355-1418

Is this the product you have?

  • Uroskop Omnia max, Model No. 10762473 -
  • Product UsageUroskop 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 therapeutic applications such as examinations and small interventions of the urogenital tract
Lot codes and dates
  • Serial Numbers

    192 of 192 codes

    • 4557
    • 4574
    • 4571
    • 4099
    • 4074
    • 4014
    • 4627
    • 4626
    • 4578
    • 4645
    • 4316
    • 4615
    • 4056
    • 4587
    • 4049
    • 4068
    • 4305
    • 4015
    • 4543
    • 4616
    • 4553
    • 4333
    • 4063
    • 4655
    • 4556
    • 4022
    • 4521
    • 4121
    • 4325
    • 4111
    • 4510
    • 4565
    • 4322
    • 4554
    • 4301
    • 4597
    • 4509
    • 4661
    • 4036
    • 4519
    • 4520
    • 4043
    • 4024
    • 4560
    • 4629
    • 4530
    • 4646
    • 4318
    • 4618
    • 4575
    • 4304
    • 4142
    • 4300
    • 4095
    • 4146
    • 4649
    • 4059
    • 4562
    • 4501
    • 4309
Amount recalled
192

This recall covers 7 products

The agency filed one notice per product. You are reading one of them; the other 6 are below.

Where it was sold

  • Nationwide

Why it was recalled

Siemens became aware of an issue of incorrect use of the bypass key overriding the built-in collision control creating risk of collision with obstacles or persons when the operator uses the override function.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jun 21, 2022 · Data as of Sep 19, 6:49 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.