Z-1331-2020Class II

Luminos dRF Max, Model No. 10762471 -

Name: Z-1331-2020 Luminos dRF Max, Model No. 10762471 -
Creator: Siemens Medical Solutions USA, Inc
Published: 2020-01-08
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2020-01-08 / Terminated

FDA source

Siemens Medical Solutions USA, Inc began a recall of Luminos dRF Max, Model No. 10762471 - Product Usage: Luminos dRF Max is a device intended to visualize anatomical structures by converting an X-ray pattern... on 2020-01-08. FDA classified it as Class II and gives the reason as "Siemens became aware of an issue of incorrect use of the bypass key overriding the built-in collision control creating risk of collision with obstacles or persons when the operator uses the override function". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1331-2020
Classification: Class II
Status: Terminated
Initiated: 2020-01-08
Posted: 2020-02-20
Terminated: 2022-06-21
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Luminos dRF Max, Model No. 10762471 - Product Usage: Luminos dRF Max is a device intended to visualize anatomical structures by converting an X-ray 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.
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: Siemens became aware of an issue of incorrect use of the bypass key overriding the built-in collision control creating risk of collision with obstacles or persons when the operator uses the override function.
FDA root cause: Use error
Action: On January 8, 2020, the firm initiated the recall, notifying customers via Urgent Medical Device Correction letters. Customers were advised of the potential for a system collision due to incorrect use of the bypass key overriding the built-in collision control. The bypass key is intended to enable movement of an otherwise blocked system to avert immediate hazard, e.g. to recover a patient following device error or in case of emergency. It is not intended for permanent use. Customers were instructed to use the bypass key exclusively to avert an immediate hazard and immediately contact Siemens Customer Service at 1-800-888-7436 to fix the issue. Siemens Healthineers will correct the error with a field software update which will be available starting in January 2020, free of charge. Your local Siemens Healthineers Service organization will contact you to arrange a date to perform this corrective action when the software update is available for your system. Customers may contact the firm's service organization for an earlier appointment at 1-800-888-7436. With this field software update, an additional acoustic signal will be introduced for an event of movement in an error situation. The signal alerts the user that the system is in the "override" state and special attention should be paid regarding possible collisions. Following the correction, the cause is eliminated, and any recurrence of this potential fault is prevented.
Quantity in commerce: 46
Distribution: US Nationwide distribution.
Product codes and lots: Serial numbers 5043 5085 5825 5234 5862 5751 5810 5188 5352 5719 5803 5812 5920 5921 5209 5069 5086 5151 5299 5372 5611 5037 5072 5947 5049 5190 5892 5961 5364 5163 5919 5355 5902 5690 5767 5954 5884 5278 5963 5956 5682 5953 5634 5951 5120 5962

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1331-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1331-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-20
Z-1332-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-20
Z-1333-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-20

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)