FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Siemens Luminos dRF Fluoroscopic X-Ray system Fluoroscopic X-Ray system
- Recall number
- Z-1848-2013
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Siemens Luminos dRF Fluoroscopic X-Ray system Fluoroscopic X-Ray system
- Status
- Terminated
- Initiated
- 2013-05-07
- Posted
- 2013-08-01
- Terminated
- 2013-12-24
- Reason
- Siemens became aware of an unintended behavior when using the Luminos dRF with software version VD10A. The possibility exists that a software error may occur causing the table to tilt into an upright position and may collide with the floor. Four consignees were notified of this recall by Update Instruction XP067/12/S -- all four units have been corrected.
- Root cause
- Software design
- Action
- Siemens initiated their correction of this product in May, 2013 by sending an Safety Update Instruction XP067/12S to resolve the software error to all affected customers. All units have been corrected. Further questions please call (610)-219-6300.
- Quantity
- 4
- Distribution
- US Distribution including the states of CA, IN, NJ and OK.
- Lot, serial or model codes
- Model number 10094200, serial numbers 4024, 4077, 4043 and 4051
- 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