CLASS II Device recall · Reported 4 Nov 2015 · FDA Enforcement Report

Cios Alpha; image intensified fluoroscopic x-ray system recalled

Siemens Medical Solutions USA is recalling Cios Alpha; image intensified fluoroscopic x-ray system, distributed nationwide in the US. The recall was initiated on 17 Aug 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesmodel #10308191 with serial numbers: Serial 11032 10073 11132 11044 11005 10115 11056 10057 10076 10019 10035 11074 11075 11077 11083 11124 10078 11119 11103 11105 11013 10021 10037 10063 11106 10082 11098 11094 10089 11080 11009 11018 11082 10058 10098 11120 11134 11015 11016 11038 10116 11035 11107 11064

Quantity recalled44

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-0118-2016
FDA event ID: 72138
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 17 Aug 2015
FDA classified: 23 Oct 2015
Reported: 4 Nov 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

17 Aug 2015	Recall initiated by company
23 Oct 2015	Classified by FDA	+67 days
4 Nov 2015	Published in enforcement report	+12 days

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

Reason for recall

patient procedure interruption due to a potential system failure

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

CIOS ALPHA; image intensified fluoroscopic x-ray system

Where it was distributed

Nationwide Distribution.

Nationwide

Questions about this recall

Why was it recalled?

patient procedure interruption due to a potential system failure

Which lots are affected?

model #10308191 with serial numbers: Serial 11032 10073 11132 11044 11005 10115 11056 10057 10076 10019 10035 11074 11075 11077 11083 11124 10078 11119 11103 11105 11013 10021 10037 10063 11106 10082 11098 11094 10089 11080 11009 11018 11082 10058 10098 11120 11134 11015 11016 11038 10116 11035 11107 11064

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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