FDA Device recall Z-0806-2021

Uroskop Omnia Max, Model no. 10762473 - Product Usage: a solid state detector fluoroscopic X-ray system, primarily for urological applicati…

FDA Device
Class II
terminated
Published 2021-01-20

On 2021-01-20 the FDA classified a Class II recall of Uroskop Omnia Max, Model no. 10762473 - Product Usage: a solid state detector fluoroscopic X-ray system, primarily for urological applicati… by Siemens Medical Solutions Usa, citing 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 int….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0806-2021
Classification	Class II
Status	terminated
Initiated	2020-09-09
Published	2021-01-20
Last updated	2026-09-13 11:56 UTC
Company	Siemens Medical Solutions Usa
Distribution	n/a

Product

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

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.

Identifiers

code_info	Serial Nos. 4557 4574 4571 4099 5051 5135 5173 5061 5193 5214 4627 4626 5072 5215 5030 4578 4645 4316… 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

code_info

Serial Nos. 4557 4574 4571 4099 5051 5135 5173 5061 5193 5214 4627 4626 5072 5215 5030 4578 4645 4316…

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0806-2021%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.