Class 2 Device Recall Uroskop Omnia max

• Date Initiated by Firm: January 08, 2020
• Create Date: February 20, 2020
• Recall Status: Terminated on June 21, 2022
• Recall Number: Z-1333-2020
• Recall Event ID: 84813
• 510(K)Number: K173639
• Product Classification: Interventional fluoroscopic x-ray system - Product Code OWB
• Product: Uroskop Omnia max, Model No. 10762473 - Product Usage: Uroskop Omnia Max is a device intended to visualize anatomical structures by converting an Xray pattern into a visible image. The system is designed primarily for urological diagnosis and the support of urological therapeutic applications such as examinations and small interventions of the urogenital tract.
• 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 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
• FEI Number: 2240869
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc; 40 Liberty Blvd; Malvern PA 19355-1418
• For Additional Information Contact: Customer Service; 800-888-7436
• Manufacturer Reason for Recall: Siemens became aware of an issue of incorrect use of the bypass key overriding the built-in collision control creating risk of collision with obstacles or persons when the operator uses the override function.
• FDA Determined Cause: Use error
• Action: On January 8, 2020, the firm initiated the recall, notifying customers via Urgent Medical Device Correction letters. Customers were advised of the potential for a system collision due to incorrect use of the bypass key overriding the built-in collision control. The bypass key is intended to enable movement of an otherwise blocked system to avert immediate hazard, e.g. to recover a patient following device error or in case of emergency. It is not intended for permanent use. Customers were instructed to use the bypass key exclusively to avert an immediate hazard and immediately contact Siemens Customer Service at 1-800-888-7436 to fix the issue. Siemens Healthineers will correct the error with a field software update which will be available starting in January 2020, free of charge. Your local Siemens Healthineers Service organization will contact you to arrange a date to perform this corrective action when the software update is available for your system. Customers may contact the firm's service organization for an earlier appointment at 1-800-888-7436. With this field software update, an additional acoustic signal will be introduced for an event of movement in an error situation. The signal alerts the user that the system is in the "override" state and special attention should be paid regarding possible collisions. Following the correction, the cause is eliminated, and any recurrence of this potential fault is prevented.
• Quantity in Commerce: 192
• 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 = OWB