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Uroskop Omnia Max, Model no. 10762473 - Product Usage: a solid state detector fluoroscopic X-ray ...

FDA Device Recall #Z-0806-2021 — Class II — September 9, 2020

Recall Summary

Recall Number Z-0806-2021
Classification Class II — Moderate risk
Date Initiated September 9, 2020
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Siemens Medical Solutions USA, Inc
Location Malvern, PA
Product Type Devices
Quantity 281

Product Description

Uroskop Omnia Max, Model no. 10762473 - Product Usage: a solid state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray diagnosis, endourology and minimal invasive urology/surgery).

Reason for Recall

After the March 2019 corrective action on the monitor support arm, there is a residual risk of the support arm becoming dislodged in cases when the monitor support arm is used intensely over a long period of time.

Distribution Pattern

Worldwide distribution.

Lot / Code Information

Serial Nos. 4557 4574 4571 4099 5051 5135 5173 5061 5193 5214 4627 4626 5072 5215 5030 4578 4645 4316 4615 4056 4587 4049 5184 4305 5045 5095 4543 4616 5062 4553 4333 4063 5200 4655 4556 4521 4121 4325 4111 4510 5188 5199 4565 4322 4554 4301 4597 4509 4661 5118 4036 5137 4519 4520 5058 4043 5116 4560 5093 4629 5134 4530 4646 5094 5067 4318 4618 4575 5090 5049 4300 4095 4146 4649 5194 4059 5070 4562 4501 4309 4548 4313 4119 4135 4069 4032 4612 4512 4053 5123 4663 5106 5144 4061 5064 4590 4593 5176 5066 4642 5060 4312 4528 4060 5174 4051 4506 4037 5057 4635 5163 4054 5133 4042 4033 4544 4566 4132 4067 4120 5198 4613 4112 4335 4336 5108 5038 5150 4072 4652 5196 5026 4055 5059 4108 4559 5088 5128 5074 4511 5020 4126 5219 4129 4104 5130 4307 5104 4334 5085 5023 5027 5021 4073 4631 4582 4570 5187 4561 5069 5208 4641 4052 4572 5033 4047 4134 4605 4326 5168 5139 5140 4603 5117 4568 4654 4532 5211 5190 4304 4142 4038 5086 5192 4102 4130 5043 4317 5099 4505 4062 5181 5152 4594 5146 5084 4096 5172 5114 5186 5164 4585 5183 4637 5025 4085 4143 4516 4662 4086 4598 4118 4573 5175 4101 4589 4100 5087 4321 4558 4591 4105 4106 4513 4098 5055 4306 4066 4310 5107 5143 4651 4624 4314 4545 4552 4082 5101 4664 4125 4328 5191 4124 5078 5159 5103 4636 4329 4128 4600 4601 4602 4659 4094 4114 4117 4136 4303 4319 5028 5122 5142 4140 4141 4500 5222 4531 4630 5124 4622 4535 4580 4660 5155 5201 4330 4332 5112 4133 4588 4609

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Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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