CLASS II Device recall · Reported 13 May 2015 · FDA Enforcement Report

Axiom Aristos Fx recalled by Siemens Medical Solutions USA

Siemens Medical Solutions USA is recalling Axiom Aristos FX; Multipurpose Radiography System (Mprs) is a dedicated x-ray system with, distributed nationwide in the US. The recall was initiated on 14 Apr 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Number of device: 7414803, Serial #s: 1008 1121 1016 1156 1157 1056 1043 1126 1076 1137 1088 1093 1030 1033 1029 1032 1100 1124 1139 1050 1058 1078 1127 1040 1035 1155 1143 1074 1109 1135 1007 1131 1110 1081 1064 1145 1146 1147 1059 1122 1140 1003 1083

Quantity recalled43

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1583-2015
FDA event ID: 71029
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 14 Apr 2015
FDA classified: 5 May 2015
Reported: 13 May 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Spinal Implants

Timeline

14 Apr 2015	Recall initiated by company
5 May 2015	Classified by FDA	+21 days
13 May 2015	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

If the cable cart and the corrugated hose are unable to move freely, the cable holder could drop down and hit patients or system operators.

Product as listed by the FDA

AXIOM ARISTOS FX; Multipurpose Radiography System (MPRS) is a dedicated x-ray system with a flat panel detector which allows the acquisition of x-ray exposures without the use of conventional film/screen systems. The MPRS allows radiographic exposures of the whole body including skull, spinal column, chest, abdomen, extremities, and excluding mammography. Radiographic exposures may be taken with the patient in the sitting, standing, or supine positions. The intended use and indications for use of this modified device as described in its labeling have not changed from its predicate device.

Where it was distributed

Nationwide Distribution.

Nationwide

Questions about this recall

Why was it recalled?

If the cable cart and the corrugated hose are unable to move freely, the cable holder could drop down and hit patients or system operators.

Which lots are affected?

Model Number of device: 7414803, Serial #s: 1008 1121 1016 1156 1157 1056 1043 1126 1076 1137 1088 1093 1030 1033 1029 1032 1100 1124 1139 1050 1058 1078 1127 1040 1035 1155 1143 1074 1109 1135 1007 1131 1110 1081 1064 1145 1146 1147 1059 1122 1140 1003 1083

Where was it sold?

Nationwide Distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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