SIEMENS Uroskop Omnia Max recall: Software Issue
SIEMENS Uroskop Omnia Max ; a solid state detector fluoroscopic X-Ray system, primarily for urological applications (functional x-ray diagnostic…
Why was SIEMENS Uroskop Omnia Max recalled?
Study and all acquired images deleted when using systems with software version VE10E. Acquisitions have to be repeated. Connection with portable detectors (MAX wi-D, MAX mini) is sporadic in image recovery. Pressing undo button on the RAD subtask card or previous series button on the Image subtask card during image readout. Sporadically, during an automatic or a manual RIS update.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model Number of device 10762473 with serial numbers: 4014 4056 4015 4063 4022 4036 4043 4024 4059 4020 4032 4053 4061 4060 4051 4025 4037 4054 4042 4033 4055 4052 4047 4049 4038 4062
- Product
- SIEMENS Uroskop Omnia Max ; a solid state detector fluoroscopic X-Ray system, primarily for urological applications (functional x-ray diagnostic…
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 133 total
- Distribution
- Nationwide Distribution.
- Recall date
- June 3, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)