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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 January 08, 2020
Create Date August 05, 2020
Recall Status1 Terminated 3 on June 21, 2022
Recall Number Z-2757-2020
Recall Event ID 85999
510(K)Number K173639  
Product Classification System, x-ray, fluoroscopic, image-intensified - Product Code JAA
Product SIEMENS Healthineers Uroskop Omnia max
Model: 10762473 - Product Usage: is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image.
Code Information Serial Numbers: 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 4548 4313 4119 4135 4069 4020 4032 4612 4512 4053 4663 4061 4590 4593 4642 4312 4528 4060 4051 4506 4025 4037 4635 4054 4042 4033 4544 4541 4566 4132 4067 4120 4613 4112 4335 4336 4072 4652 4055 4108 4559 4511 4540 4126 4129 4104 4307 4334 4073 4631 4582 4570 4561 4641 4052 4572 4047 4134 4605 4326 4529 4603 4568 4654 4532 4102 4130 4317 4505 4062 4594 4096 4585 4637 4085 4143 4516 4662 4086 4598 4118 4573 4101 4589 4100 4321 4558 4591 4105 4106 4513 4538 4098 4537 4306 4539 4066 4310 4651 4624 4314 4545 4552 4082 4664 4125 4328 4124 4636 4329 4600 4601 4602 4094 4114 4117 4136 4303 4319 4140 4141 4500 4531 4630 4622 4535 4580 4660 4330 4332 4133 4588 4609 
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355
For Additional Information Contact SAME
610-219-4834
Manufacturer Reason
for Recall		 Two software issues (1) Using the override function in case of blocked system movements affecting Luminos dRF Max, Luminos Agile Max and Uroskop Omnia Max systems may cause collision of the system under operator control with obstacles or persons .(2) Incorrectly assigned image affecting Ysio Max, Luminos dRF Max and Luminos Agile Max systems with detector MAX Static causing incorrect base for diagnosis
FDA Determined
Cause 2		 Device Design
Action Siemens Medical Solutions USA, Inc. has initiated a Customer Safety Advisory Notice to all affected customers via XP028/19/S January 2020. Additionally, a solution to eliminate the root cause of this problem is being distributed via XP008/20/S March 2020. Following the corrective action, the cause is eliminated and a recurrence of the fault is prevented. New corrective software VE10Y became available June 22, 2020, and it is being distributed via an Update Instruction XP008/20/S. This update fixes the initial reported issue and the sporadic image loss issue noted by customers who had already installed VE10W (XP029/19/S). The original Customer Safety Advisory Notice (XP028/19/S) and the information letter distributed in March 2020 remain applicable. This resolution will be provided free of charge. Your local Siemens Healthineers Service organization will contact you to arrange a date to perform this corrective action . Questions contact the service organization for an earlier appointment at 1-800-888-7436
Quantity in Commerce 194 units
Distribution US Nationwide 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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