Z-1669-2015Class II

SIEMENS Luminos Agile Max; a universal imaging system for radiographic and fluoroscopic studies. Using either...

Name: Z-1669-2015 SIEMENS Luminos Agile Max; a universal imaging system for radiographic and fluoroscopic studies. Using either...
Creator: Siemens Medical Solutions USA, Inc
Published: 2015-04-13
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2015-04-13 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of SIEMENS Luminos Agile Max; a universal imaging system for radiographic and fluoroscopic studies. Using either film cassettes or a digital mobile flat detector... on 2015-04-13. FDA classified it as Class II and gives the reason as "Study and all acquired images deleted when using systems with software version VE10E. Acquisitions have to be repeated. Connection with portable detectors (MAX wi-D, MAX mini) is sporadic in image recovery. Pressing...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1669-2015
Classification: Class II
Status: Terminated
Initiated: 2015-04-13
Posted: 2015-05-23
Terminated: 2017-03-20
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: SIEMENS Luminos Agile Max; a universal imaging system for radiographic and fluoroscopic studies. Using either film cassettes or a digital mobile flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. Luminos Agile is applicable to emergency treatment on an outpatient basis, as well as for bedside examinations.
Product code: JAA System, X-Ray, Fluoroscopic, Image-Intensified
Reason for recall: Study and all acquired images deleted when using systems with software version VE10E. Acquisitions have to be repeated. Connection with portable detectors (MAX wi-D, MAX mini) is sporadic in image recovery. Pressing undo button on the RAD subtask card or previous series button on the Image subtask card during image readout. Sporadically, during an automatic or a manual RIS update.
Root cause tag: software
FDA root cause: Software design
Action: A safety advisory notice, dated April 13, 2015, was sent to end users with affected devices to alert them about the issue and associated risks,and to provide instructions for avoiding potential risk. A new software version will be released to permanently resolve the issue.
Quantity in commerce: 133 total
Distribution: Nationwide Distribution.
Product codes and lots: Model Number of device 10762472 with serial numbers: 61034 61052 61045 61013 61054 61056 61021 61050 61053 61032 61015 61046 61028 61040 61011 61029 61048 61060 61042 61035 61014 61025 61043 61036 61038 61022 61037 61049 61044 61062 61030 61018 61027 61061 61033 61039 61047 61031 61041 61055 61019 61057 61059 61017 61051

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1669-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1667-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-03	2015-05-23
Z-1668-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-03	2015-05-23
Z-1669-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-03	2015-05-23
Z-1670-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-03	2015-05-23

Product code JAA

K111292Class IILuminos AgileSiemens Medical Solutions USA, Inc. / cleared 2011-06-03

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)