FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: AXIOM Luminos dRF system with SW VD10 or on Luminos dRF Max The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. The Axiom Luminos dRF is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image.
- Recall number
- Z-2649-2014
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- AXIOM Luminos dRF system with SW VD10 or on Luminos dRF Max The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. The Axiom Luminos dRF is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image.
- Status
- Terminated
- Initiated
- 2014-08-12
- Posted
- 2014-09-16
- Terminated
- 2015-05-21
- Reason
- It was determined that a potential malfunction may occur on the Luminos dRF system with SW VD10 or on Luminos dRF Max when the table side control is exposed to fluids. Fluid may infiltrate the tableside control panel and result in malfunction. In the very unlikely case of fluid infiltration a permanent short circuit within the control panel of the Luminos dRF / Luminos dRF Max will automatically d
- Root cause
- Equipment maintenance
- Action
- Siemens sent a Customer Safety Advisory Notice XP045/14/S, dated August 12, 2014, to direct accounts, which identified the product, problem, and action to be taken to avoid potential risk to patients and users. Customers were instructed to avoid extensive exposure of fluids to the tableside control panel. When cleaning the system, customers were instructed not to appoly excessive fluids, only use damp towels, in accordance with the product manual. Customers were asked to forward the safety notice to any of their customers and to inform Siemens of the identify of the device's new owner where possible. For questions regarding this recall call 610-219-6300.
- Quantity
- 33
- Distribution
- Nationwide Distribution including IL VA TN PA TX IN MN NM GA MI FL CA NY ME OK MO NJ and AZ.
- Lot, serial or model codes
- model # 10094200, see distribution list for individual device serial numbers
- 510(k) numbers
- ["K062623"]
- 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