Data Foundry

Medical device recalls 2013

Siemens Luminos dRF Fluoroscopic X-Ray system Fluoroscopic X-Ray… — Class II medical device recall Z-1848-2013

Terminated recall by Siemens Medical Solutions USA, Inc, reported 2013-08-07, distributed in CA, IN, NJ, OK. Siemens became aware of an unintended behavior when using the Luminos dRF with software version VD10A. The pos

Recall numberZ-1848-2013
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmSiemens Medical Solutions USA, Inc, Malvern, PA, United States
Recall initiated2013-05-07
Classified2013-08-01
Reported by FDA2013-08-07
Terminated2013-12-24
DistributedCA, IN, NJ, OK
Quantity4
Reason classessoftware
Serial numbers4024, 4043, 4051, 4077
Model numbers10094200

Product

Siemens Luminos dRF Fluoroscopic X-Ray system Fluoroscopic X-Ray system

Reason for recall

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.

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-1848-2013. 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.