Data Foundry

Medical device recalls 2013

Axiom Aristos MX Solid State Flat Panel Digital Imager — Class II medical device recall Z-1795-2013

Terminated recall by Siemens Medical Solutions USA, Inc, reported 2013-07-31, distributed nationwide. Siemens issued a Field Safety Notice about the potential hazard to patients or operators when using the functi

Recall numberZ-1795-2013
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmSiemens Medical Solutions USA, Inc, Malvern, PA, United States
Recall initiated2013-06-05
Classified2013-07-24
Reported by FDA2013-07-31
Terminated2015-02-24
DistributedNationwide (US)
Quantity401
Serial numbers1052
Model numbers5895003

Product

Axiom Aristos MX Solid State Flat Panel Digital Imager, Model number 5895003. The device is used for diagnostic X-ray imaging.

Reason for recall

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1795-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.