FDA recall Z-1002-2023

Siemens Medical Solutions USA, Inc · Class II · device

Product

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

Reason for recall

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.

Distribution

Worldwide distribution

Key facts

Status
Ongoing
Initiation date
2022-12-09
Report date
2023-01-25
Voluntary/Mandated
Voluntary: Firm initiated
Location
Malvern, PA, United States

Primary source

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