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U.S. Department of Health and Human Services

Class 2 Device Recall Uroskop Omnia Max

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  Class 2 Device Recall Uroskop Omnia Max see related information
Date Initiated by Firm September 09, 2020
Create Date January 08, 2021
Recall Status1 Terminated 3 on April 16, 2021
Recall Number Z-0806-2021
Recall Event ID 86985
510(K)Number K173639  
Product Classification System, x-ray, fluoroscopic, image-intensified - Product Code JAA
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).
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 
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355
For Additional Information Contact Anastasia Sokolova
610-219-4834
Manufacturer 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.
FDA Determined
Cause 2		 Device Design
Action On September 9, 2020, the firm distributed Urgent Medical Device Correction letters to affected customers. Customers were informed that the firm has released an additional safety measure to avoid the potential issue. A safety gear will be installed into the monitor support arm out of an abundance of caution. The corrective action is available and is being provided to affected users free of charge. The firm will contact customers to arrange a date to perform the corrective action. Please feel free to contact the firm to schedule an earlier appointment at 1-800-888-7436.
Quantity in Commerce 281
Distribution Worldwide distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JAA and Original Applicant = Siemens Medical Solutions, Inc
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