Agency classClass IIOur severity:High FDA (Devices)·Z-1083-2013·Announced 2013-04-17

GE Healthcare Recalls VMX Mobile X-ray Units Due to Arm Base Casting Issue

GE Healthcare is recalling VMX and VMX Plus mobile X-ray units because a defect in the arm base casting may impact operator or patient safety.

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: The recall is classified as FDA Class II, and the source text states the defect 'may impact Operator or Patient safety' without reporting specific injuries or fatalities, fitting the criteria for a high-risk product where injury has not yet been reported.

Plain-English summary

GE Healthcare, LLC is recalling 1,296 units of the VMX and VMX Plus Mobile Radiographic Units. The recall involves specific models including 45296139, 45296200, and 2240169, among others. These units are mobile radiography systems designed for use in intensive care, emergencies, pediatrics, neonatology, and orthopedics.

The recall is being issued because GE Healthcare has identified an issue with the base casting for the articulated arm of the systems. This defect may impact the safety of operators or patients. The affected units were distributed worldwide, including in the United States and numerous international locations such as Canada, Germany, and Brazil.

Healthcare facilities and users should check their equipment serial numbers against the list provided in the official recall notice. If a unit is affected, it should be taken out of service and the manufacturer contacted for instructions on repair or replacement.

The recalled product

Product: VMX, VMX Plus Mobile Radiographic Unit with the following models: 45296139; 45296200; 45296350; 45296477; 45296964; 45297001; 45296966; 45297003; 2240169; 2240171; 2240172; 2240173. Product Usage: The VMX is a mobile radiography system incorporating stylish design for…
Manufacturer: GE Healthcare, LLC
Category: Medical Device — Mobile X-ray Systems
Hazard: structural-defect
patient-safety
Affected units: 1,296

Distribution

Distributed nationwide across the United States.

The notice also names 15 states specifically:

Same manufacturer · GE Healthcare, LLC

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