CLASS II Device recall · Reported 13 Mar 2019 · FDA Enforcement Report

Uroskop Omnia Max -fluoroscopic X-ray system recalled

Siemens Medical Solutions USA is recalling Uroskop Omnia Max -fluoroscopic X-ray system, distributed nationwide in the US. The recall was initiated on 8 Feb 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Numbers: 4032 4033 4036 4037 4038 4042 4043 4047 4052 4053 4054 4055 4056 4059 4060 4061 4063 4066 4069 4072 4073 4082 4085 4086 4094 4095 4096 4098 4099 4100 4101 4102 4104 4108 4111 4112 4114 4117 4118 4119 4120 4121 4124 4125 4126 4128 4129 4130 4132 4133 4134 4135 4136 4140 4141 4142 4143 4146 4300 4301 4303 4304 4305 4306 4309 4310 4312 4313 4314 4317 4318 4319 4321 4322 4325 4326 4328 4329 4330 4332 4333 4334 4500 4501 4505 4506 4509 4510 4511 4513 4516 4519 4520 4521 4528 4529 4530 4531 4532 4543 4544 4545 4548 4552 4553 4556 4557 4558 4559 4560 4561 4562 4565 4566 4568 4571 4572 4573 4574 4575 4578 4582 4585 4587 4588 4589 4590 4591 4593 4594 4597 4598 4600 4601 4602 4603 4605 4609 4613 4615 4616 4618 4622 4624 4626 4627 4629 4630 4631 4635 4636 4637 4641 4642 4645 4646 4649 4651 4652 4655 4659 4661 4662 4663 4664 5020 5021 5023 5025 5026 5027 5028 5030 5031 5033 5038 5043 5045 5051 5057 5058 5059 5060 5061 5066 5067 5069 5070 5072 5074 5078

Quantity recalled191

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0985-2019
FDA event ID: 82211
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 8 Feb 2019
FDA classified: 7 Mar 2019
Reported: 13 Mar 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

8 Feb 2019	Recall initiated by company
7 Mar 2019	Classified by FDA	+27 days
13 Mar 2019	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

Uroskop Omnia Max -fluoroscopic X-ray system Model # 10762473 Uroskop Omnia Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image.

Where it was distributed

US Nationwide Distribution

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Serial Numbers: 4032 4033 4036 4037 4038 4042 4043 4047 4052 4053 4054 4055 4056 4059 4060 4061 4063 4066 4069 4072 4073 4082 4085 4086 4094 4095 4096 4098 4099 4100 4101 4102 4104 4108 4111 4112 4114 4117 4118 4119 4120 4121 4124 4125 4126 4128 4129 4130 4132 4133 4134 4135 4136 4140 4141 4142 4143 4146 4300 4301 4303 4304 4305 4306 4309 4310 4312 4313 4314 4317 4318 4319 4321 4322 4325 4326 4328 4329 4330 4332 4333 4334 4500 4501 4505 4506 4509 4510 4511 4513 4516 4519 4520 4521 4528 4529 4530 4531 4532 4543 4544 4545 4548 4552 4553 4556 4557 4558 4559 4560 4561 4562 4565 4566 4568 4571 4572 4573 4574 4575 4578 4582 4585 4587 4588 4589 4590 4591 4593 4594 4597 4598 4600 4601 4602 4603 4605 4609 4613 4615 4616 4618 4622 4624 4626 4627 4629 4630 4631 4635 4636 4637 4641 4642 4645 4646 4649 4651 4652 4655 4659 4661 4662 4663 4664 5020 5021 5023 5025 5026 5027 5028 5030 5031 5033 5038 5043 5045 5051 5057 5058 5059 5060 5061 5066 5067 5069 5070 5072 5074 5078

Where was it sold?

US Nationwide Distribution

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 82211

Reported	Class	Recall	Company	Reason	Where
13 Mar 2019	CLASS II	Uroskop Omnia -fluoroscopic X-ray system recalled	Siemens Medical Solutions USA	Other	Nationwide

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