FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: 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.
- Recall number
- Z-1669-2015
- 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.
- Status
- Terminated
- Initiated
- 2015-04-13
- Posted
- 2015-05-23
- Terminated
- 2017-03-20
- Reason
- 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
- 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
- 133 total
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K111292"]
- PMA numbers
- not on file
- Product code
- JAA
- Firm FEI
- 2240869
- Firm city
- Malvern
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28