FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Axiom Luminos dRF Intended use: solid state x-ray imager (flat panel/digital imager)
- Recall number
- Z-0717-2011
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Axiom Luminos dRF Intended use: solid state x-ray imager (flat panel/digital imager)
- Status
- Terminated
- Initiated
- 2010-10-25
- Posted
- 2010-12-17
- Terminated
- 2012-09-29
- Reason
- patient leg can be pinched
- Root cause
- Other
- Action
- SIEMENS sent a Customer Safety Advisory Notice dated October 25, 2010, to affected customers via Update Instructions AX072/10/S. The notice described the issue and the actions to be taken by customers. The customers were instructed to retain the annex together with their operating instructions and bring the hazard to the attention of their employees; inform all users and other persons of this notice; if they sold the device, forward this notice and attachment to the new owners of the device and provide SIEMENS with details of the new owners. If you have any questions, please contact +1-888-826-9702.
- Quantity
- 24 units
- Distribution
- Nationwide distribution: CA, CO, FL, GA, IL, IN, KY, MI, MN, MO, NC, NJ, and NY.
- Lot, serial or model codes
- Model number 10094200. Serial numbrs: 1148, 1149, 1182, 1191, 1194, 1221, 1224, 1250, 1265, 1316, 1327, 1358, 1410, 1419, 1443, 2022, 2024, 2025, 2049, 2054, 2069, 2070, 2076, and 2092.
- 510(k) numbers
- ["K062623"]
- PMA numbers
- not on file
- Product code
- MQB
- 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