Class 2 Device Recall Uroskop Omnia Max

• Date Initiated by Firm: February 08, 2019
• Create Date: March 07, 2019
• Recall Status: Terminated on May 05, 2020
• Recall Number: Z-0985-2019
• Recall Event ID: 82211
• 510(K)Number: K173639
• Product Classification: Interventional fluoroscopic x-ray system - Product Code OWB
• Product: Uroskop Omnia Max -fluoroscopic X-ray system Model # 10762473 Uroskop Omnia Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image.
• Code Information: Serial Numbers: 4032 4033 4036 4037 4038 4042 4043 4047 4052 4053 4054 4055 4056 4059 4060 4061 4063 4066 4069 4072 4073 4082 4085 4086 4094 4095 4096 4098 4099 4100 4101 4102 4104 4108 4111 4112 4114 4117 4118 4119 4120 4121 4124 4125 4126 4128 4129 4130 4132 4133 4134 4135 4136 4140 4141 4142 4143 4146 4300 4301 4303 4304 4305 4306 4309 4310 4312 4313 4314 4317 4318 4319 4321 4322 4325 4326 4328 4329 4330 4332 4333 4334 4500 4501 4505 4506 4509 4510 4511 4513 4516 4519 4520 4521 4528 4529 4530 4531 4532 4543 4544 4545 4548 4552 4553 4556 4557 4558 4559 4560 4561 4562 4565 4566 4568 4571 4572 4573 4574 4575 4578 4582 4585 4587 4588 4589 4590 4591 4593 4594 4597 4598 4600 4601 4602 4603 4605 4609 4613 4615 4616 4618 4622 4624 4626 4627 4629 4630 4631 4635 4636 4637 4641 4642 4645 4646 4649 4651 4652 4655 4659 4661 4662 4663 4664 5020 5021 5023 5025 5026 5027 5028 5030 5031 5033 5038 5043 5045 5051 5057 5058 5059 5060 5061 5066 5067 5069 5070 5072 5074 5078
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc; 40 Liberty Blvd; Malvern PA 19355-1418
• For Additional Information Contact: 610-219-4834
• Manufacturer Reason for Recall: The swivel arm holding the monitors may become dislodged from the carrying arm.
• FDA Determined Cause: Device Design
• Action: The firm, Siemens, issued an "URGENT: MEDICAL DEVICE CORRECTION "on 2/8/19 to its customers. The letter is identifying the problem, risk, actions to take and corrective action. The customers were instructed to do the following: Immediately examine your inventory and quarantine product subject to recall (if applicable). or To avoid the risk until implementation of the corrective action, it is strongly recommended not to move and position monitors above the system table. As an alternative and if clinically applicable, monitors can also be used when they are left in the parking position. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. If the device has been sold and is therefore no longer in your possession, please forward this notice to the new owner. The service organization will contact and arrange a date to perform this corrective action with Updated Instruction XP006/19/S. Contact the service organization for an earlier appointment at 1-800-888-7436.
• Quantity in Commerce: 191
• 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