FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Axiom Aristos MX Solid State Flat Panel Digital Imager, Model number 5895003. The device is used for diagnostic X-ray imaging.
- Recall number
- Z-1795-2013
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Axiom Aristos MX Solid State Flat Panel Digital Imager, Model number 5895003. The device is used for diagnostic X-ray imaging.
- Status
- Terminated
- Initiated
- 2013-06-05
- Posted
- 2013-07-24
- Terminated
- 2015-02-24
- Reason
- Siemens issued a Field Safety Notice about the potential hazard to patients or operators when using the function "table top float" of the AXIOM Aristos MX. When repositioning a patient lying on the table top and releasing the table top, it is possible that the fingers of the patient or operator are between the table top and the detector tray and if the table top is moved, the fingers can be squee
- Root cause
- Device Design
- Action
- On 6/5/13, consignees were notified by letter of a "Field Safety Notice" and received instructions about how to avoid the potential risk of this issue while using the device. Siemens also rolled out a modification of AXIOM Aristos MX that will avoid these potential injuries in the future.
- Quantity
- 401
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- Model Number 5895003 with serial numbers 1052 through 2500.
- 510(k) numbers
- ["K983732"]
- 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