The Recall Desk
SevereFDA (Devices)·Z-1957-2020·Announced 2020-05-20

Siemens Cios Alpha Mobile X-Ray System Recalled for Electrical Shock Risk

Siemens is recalling four Cios Alpha mobile X-ray systems because unplugging the main cable during a clinical session can expose users to unsafe electrical voltage.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a risk of electrical shock (125 V DC) which constitutes a significant injury risk, aligning with the rubric criteria for a Severe (4) classification.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling four units of the Cios Alpha VA20-mobile X-Ray system (Material # 10308191). The affected serial numbers are 12425, 109, 10063, and 12946. These units were distributed nationwide in the United States.

The recall is due to a safety hazard where the main cable can be unplugged from the X10 connector on the main unit (c-arm) at any time during a clinical session. If the system displays the error message Err 16305 / 80, unplugging the main cable can cause an unsafe electrical voltage of 125 V DC at the X10 connector. This can result in an electrical shock if a user or other persons touch the contact pins, which are accessible when the cable is unplugged.

Healthcare facilities and users should stop using the affected units and contact Siemens Medical Solutions USA, Inc. for instructions on corrective actions.

The recalled product

Product
Siemens Cios Alpha VA20-mobile X-Ray system Material # 10308191 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.
Manufacturer
Siemens Medical Solutions USA, Inc
Category
Medical Device — Imaging Equipment
Hazard
Affected units
4

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • Serial Numbers: 12425
  • 109
  • 10063
  • 12946

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Siemens Medical Solutions USA, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · Siemens Medical Solutions USA, Inc

See all →

Same hazard · electrical shock

See all →