CLASS II Device recall · Reported 20 May 2020 · FDA Enforcement Report

Siemens Cios Alpha VA30-mobile X-Ray system recalled

Siemens Medical Solutions USA is recalling Siemens Cios Alpha VA30-mobile X-Ray system, Material # 11105200 The Cios Alpha and Cios, distributed nationwide in the US. The recall was initiated on 20 Apr 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Numbers: 40057 40047 40048 40107 40108 40111 40120 40126 40134 40135 40032 40104 40075 40102 40124 40070

Quantity recalled16 units

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-1958-2020
FDA event ID: 85553
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 20 Apr 2020
FDA classified: 11 May 2020
Reported: 20 May 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

20 Apr 2020	Recall initiated by company
11 May 2020	Classified by FDA	+21 days
20 May 2020	Published in enforcement report	+9 days

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

Reason for recall

Main cable can be plugged or unplugged from the X10 connector which is part of the main unit (c-arm) at any time during clinical session. If the system displays the error message Err 16305 / 80, the unplugging of the main cable can cause an unsafe electrical voltage (125 V DC) at the X10 connector and result in an electrical shock if the user or other persons touch the contact pins of the X10 connector. These contact pins are accessible when the main cable is unplugged from the X10 connector

Product as listed by the FDA

Siemens Cios Alpha VA30-mobile X-Ray system, Material # 11105200 The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications.

Where it was distributed

US Nationwide distributions.

Nationwide

Questions about this recall

Is Siemens Cios Alpha VA30-mobile X-Ray system, Material # 11105200 The Cios Alpha and Cios recalled?

Yes. Siemens Medical Solutions USA recalled Siemens Cios Alpha VA30-mobile X-Ray system, Material # 11105200 The Cios Alpha and Cios on 20 Apr 2020. The recall is Class II and its status is Terminated. Recall number Z-1958-2020.

Why was it recalled?

Which lots are affected?

Serial Numbers: 40057 40047 40048 40107 40108 40111 40120 40126 40134 40135 40032 40104 40075 40102 40124 40070

Where was it sold?

US Nationwide distributions.

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 21 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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