Siemens recalls Luminos Agile Max, dRF Max, and Lotus Max models due to potential footrest detachment during use, which could cause injury. Affected units have specific serial numbers and are used in medical imaging.
There is potential for the footrest to detach from the patient table during use. Device intended to visualize anatomical structures by converting an Xray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoracic and lung exposures as well as examinations of the urogenital tract. The unit may also be used in emergency applications, lymphography, endoscopy, myelography, venography, arthrography, interventional radiology, digital angiography, and digital subtraction angiography (DSA). The system may be used on pediatric, adult, and bariatric patients. These devices are not for mammography examinations.
Siemens is recalling three medical imaging systems (Luminos Agile Max, dRF Max, and Lotus Max) because the footrest might detach from the patient table during use. This could lead to injury if the patient or equipment is not properly secured.
The footrest could detach from the patient table during use, potentially causing injury to the patient or staff. This risk occurs when the device is operating in medical settings where patients are positioned on the table.
Healthcare providers using these medical imaging systems for X-ray procedures on patients are affected. Patients undergoing scans with these devices may be at risk if the footrest detaches.
Check for the specific model names: Luminos Agile Max, dRF Max, or Lotus Max. Look for the serial numbers listed: 10762472, 10762471, or 11574100.
Identify the model name and serial number from the device's label to confirm if it is affected.
The footrest could detach from the patient table during use, potentially causing injury to patients or staff.
Check for the model names: Luminos Agile Max, dRF Max, or Lotus Max, and the specific serial numbers listed in the recall notice.
The recall record does not specify a remedy, so no immediate action is required beyond checking if the device is affected.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-1002-2023 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-1002-2023 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.
