Data Foundry

Medical device recalls 2013

Iconos R200 C20 — Class II medical device recall Z-1097-2013

Terminated recall by Siemens Medical Solutions USA, Inc, reported 2013-04-17, distributed nationwide. Siemens has become aware of a potential malfunction and possible hazard to patients and staff when using the I

Recall numberZ-1097-2013
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmSiemens Medical Solutions USA, Inc, Malvern, PA, United States
Recall initiated2013-01-15
Classified2013-04-11
Reported by FDA2013-04-17
Terminated2013-04-23
DistributedNationwide (US)
Quantity51
Reason classesdevice malfunction
Serial numbers1003, 1007, 1219, 1228, 1401, 1402, 1405, 1413, 1444, 1477, 1484, 1601, 1610, 1612, 1632, 1663, 2037, 2038, 2068, 2132, 2153, 2156, 2166, 2180, 2190 and 26 more
Model numbers10093962, 5902767, 5902783, 7152478

Product

Iconos R200 C20, Iconos R200 T20, Iconos R100, Iconos MD, Iconos RHD, Luminos RF Classic, Luminos Fusion or Luminos Select. Angiographic x-ray system.

Reason for recall

Siemens has become aware of a potential malfunction and possible hazard to patients and staff when using the Iconos R200 C20, Iconos R200 T20, Iconos R100, Iconos MD, Iconos RHD, Luminos RF Classic, Luminos Fusion or Luminos Select. This malfunction is possible in cases where the table vertical lift movement is obstructed by a solid object which could potentially result in collision. This can re

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-1097-2013. 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.