Siemens recalls Uroskop Omnia model 10094910 X-ray systems due to risk of support arm dislodging after prolonged intense use. Affected units have specific serial numbers.
After the March 2019 corrective action on the monitor support arm, there is a residual risk of the support arm becoming dislodged in cases when the monitor support arm is used intensely over a long period of time.
Siemens is recalling Uroskop Omnia X-ray systems that could have a support arm that becomes dislodged after long periods of heavy use. This could lead to injury if the arm moves unexpectedly during medical procedures.
The support arm can become dislodged after prolonged intense use, which might cause it to move unexpectedly during medical procedures. This could lead to injury to the patient or healthcare provider.
Healthcare professionals using the Uroskop Omnia X-ray system for urological procedures are most at risk. Patients undergoing these procedures may also be affected if the system malfunctions.
Check for the model number 10094910 on the Uroskop Omnia X-ray system. Affected units have specific serial numbers: 3417, 3414, 3415, 3418, 3428, 3416.
Inspect the support arm for signs of dislodgement after prolonged heavy use, especially if the system has been used intensively over time.
After a March 2019 corrective action, there is a residual risk of the support arm becoming dislodged when used intensely over a long period of time.
The affected model number is 10094910 with specific serial numbers: 3417, 3414, 3415, 3418, 3428, 3416.
The recall record does not specify a remedy or fix for this issue.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-0805-2021 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-0805-2021 from Siemens. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
