Agency classClass IIOur severity:High FDA (Devices)·Z-2240-2023·Announced 2023-08-02

Mobile X-ray System with Faulty Glue Assembly May Pose Electric Shock Hazard

Siemens Mobile X-ray systems may have incorrect glue on the tank cover assembly, which could fall off and allow liquid ingress, creating electric shock risk. The recall affects 9 units distributed in the US and internationally.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This recall describes a risk-of-harm scenario (electric shock from liquid ingress through a defective glue joint) but with no reported illnesses or injuries. The FDA Class II classification and the explicit risk of electric shock support a High severity rating. Per the rubric, a risk-of-harm product without reported injury is scored at 3.

Plain-English summary

The Cios Select VA 21 with FD-A Mobile X-ray system manufactured by Siemens Medical Solutions USA, Inc. is subject to this recall.

The tank cover assembly on these units contains a plexiglass sheet affixed with incorrect glue. The faulty adhesive may allow the plexiglass sheet to detach. If the plexiglass falls off, liquid may enter the equipment and contact internal live electrical parts, creating a risk of electric shock to users or operators who touch the contaminated area.

This recall affects 9 units that were distributed worldwide. In the United States, units were distributed to Florida, Georgia, Kansas, Minnesota, North Carolina, and New York. International distribution includes Austria, Bangladesh, Brazil, Canada, China, Croatia, El Salvador, France, Germany, Indonesia, Italy, Japan, Jordan, Lebanon, Luxembourg, Mauritius, Mexico, Monaco, Peru, Philippines, Poland, Romania, Slovakia, South Africa, Spain, Switzerland, Taiwan, Ukraine, and the United Kingdom.

The recalled product

Product: Cios Select VA 21 with FD- A Mobile X-ray system intended for use in Operating room, Traumatology, Endoscopy, Intensive Care Station, Pediatrics, Ambulatory patient care and in Veterinary Medicine. Material #11515088
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — Diagnostic Imaging Equipment
Hazard: electrical-shock
liquid-ingress
equipment-defect
Affected units: 9

Distribution

Distributed nationwide across the United States.

The notice also names 6 states specifically:

Same manufacturer · Siemens Medical Solutions USA, Inc

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