SEDECAL recalls Soltus 450 and 500 Battery Mobile X-Ray Systems due to uncommanded movement. Affected units have specific serial numbers and UDI codes. Stop using immediately to prevent potential injury.
Due to un-commanded movement of mobile x-ray unit.
SEDECAL is recalling Soltus 450 and 500 Battery Mobile X-Ray Systems because they can move unexpectedly while in use. This poses a risk of injury if the unit tips over or falls. Affected units have specific serial numbers and UDI codes listed in the recall.
The mobile x-ray unit can move unexpectedly during operation, which may cause it to tip over or fall. This poses a risk of injury to people in the vicinity, such as medical staff or patients.
Healthcare facilities and medical professionals who use these mobile x-ray systems are most at risk. The uncommanded movement could cause the unit to tip over, potentially injuring people nearby.
Check if your unit has a serial number starting with SLS000002 to SLS000180 or a UDI code matching the listed numbers. The Soltus 450 and 500 models are affected.
Immediately stop using the affected mobile x-ray unit to prevent potential injury from uncommanded movement.
The Soltus 450 and Soltus 500 Battery Mobile X-Ray Systems with specific serial numbers and UDI codes listed in the recall are affected.
Check if your unit has a serial number starting with SLS000002 to SLS000180 or a UDI code matching the listed numbers in the recall.
Immediately stop using the affected unit and contact SEDECAL for further instructions.
We’ve drafted a message you can send SEDECAL to request your refund or repair — edit it as you like.
Subject: Recall Z-0182-2023 — SEDECAL SEDECAL Hello, I own a SEDECAL that is covered by recall Z-0182-2023 from SEDECAL. 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.
