FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471
- Recall number
- Z-0999-2026
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471
- Status
- Open, Classified
- Initiated
- 2025-12-05
- Posted
- 2026-01-08
- Terminated
- not on file
- Reason
- A potential issue associated with LUMINOS Lotus Max and Luminos dRF Max systems with software version VF11 with bucky wall stand for mobile detectors and without ceiling stand .When switching quickly between organ programs (OGPs) the collimation may be incorrect.
- Root cause
- Radiation Control for Health and Safety Act
- Action
- The Customer Advisory Notice (CAN) was sent to the affected customer on December 5, 2025. The CAN notifies the customer of the problem and provides steps the user should take to avoid the problem until the resolution software update is available. When switching within five seconds from a table related OGP to a bucky wall stand related OGP with top-alignment and then back to a table related OGP, it may happen, that the collimation is not adapted to the limitations of the detector. The active radiation field may thus extend beyond the limits of the detector, resulting in radiation outside of the area of the detector.
- Quantity
- U.S.: 1, OUS: 95
- Distribution
- U.S. and OUS
- Lot, serial or model codes
- (01)04056869269931(21)10330
- 510(k) numbers
- ["K173639"]
- PMA numbers
- not on file
- Product code
- OWB
- 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