FDA-Device2023-01-25Class II

Luminos Agile Max, Luminos dRF Max, and LUMINOS Lotus Max

Siemens Medical Solutions USA, Inc
Hazard

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.

Sold states
Worldwide distribution
Affected count
886 units
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
Luminos Agile Max, Luminos dRF Max, and LUMINOS Lotus Max

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1002-2023

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief