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SIEMENS Healthineers Uroskop Omnia max Model: 10762473 - Product Usage: is a device intended to...

FDA Device Recall #Z-2757-2020 — Class II — January 8, 2020

Recall Summary

Recall Number Z-2757-2020
Classification Class II — Moderate risk
Date Initiated January 8, 2020
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Siemens Medical Solutions USA, Inc
Location Malvern, PA
Product Type Devices
Quantity 194 units

Product Description

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.

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

Distribution Pattern

US Nationwide distribution.

Lot / 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

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Frequently Asked Questions

A software recall means the device's embedded software or firmware has a defect that could affect its performance or safety. Many software recalls are corrected through firmware updates that can be applied without physically replacing the device. For implantable devices, the update may be delivered wirelessly during a routine clinic visit. For external devices, the manufacturer may provide updated software files or replacement units. Contact your healthcare provider to determine whether your specific device and software version are affected and what action is recommended.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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