Z-1002-2023 Class II Ongoing
FDA device recall Z-1002-2023 was initiated by Siemens Medical Solutions USA, Inc on Dec 9, 2022 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 886 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 25, 2023
- Initiation Date
- Dec 9, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 886 units
Product Description
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 Pattern
Worldwide distribution
Code Information
All serial numbers 1) Luminos Agile Max, Material #10762472, UDI/DI: 4056869009162 2) Luminos drF Max, Material #10762471, UDI/DI: 4056869009155 3) Luminos Lotus Max, Material #11574100, UDI/DI: 4056869269331
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1002-2023
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026