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.
What this means for you
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
- Hazard
- electrical-shock
- liquid-ingress
- equipment-defect
Distribution
Distributed nationwide across the United States.
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