Z-1002-2023Class II

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

Name: Z-1002-2023 Luminos Agile Max, Luminos dRF Max, and LUMINOS Lotus Max
Creator: Siemens Medical Solutions USA, Inc
Published: 2022-12-09
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2022-12-09 / Open, Classified / root cause: manufacturing process

FDA source

Siemens Medical Solutions USA, Inc began a recall of Luminos Agile Max, Luminos dRF Max, and LUMINOS Lotus Max on 2022-12-09. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1002-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-12-09
Posted: 2023-01-20
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Luminos Agile Max, Luminos dRF Max, and LUMINOS Lotus Max
Product code: OWB Interventional Fluoroscopic X-Ray System
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: A Customer Safety Advisory Notification (CSAN) was distributed to affected consignees beginning December 9, 2022. The CSAN was distributed to inform the customers about a preventative measure to exclude any potential risk of patient injury caused by the footrest detaching from the patient table during examination. Together with the CSAN, an addendum to the operator manual is distributed containing additional details and illustrations on how to securely attach the footrest to further improve the understanding of handling the footrest. Refer to the CSAN with addendum and copies of the Instructions for Use for each reported system.
Quantity in commerce: 886 units
Distribution: Worldwide distribution
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1002-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1000-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-25	2023-01-19
Z-1001-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-25	2023-01-19
Z-1002-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-25	2023-01-19

Product code OWB

K173639Class IILuminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom RaxSiemens Medi Cal Solutions, Inc. / cleared 2018-04-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)