Agency classClass IIOur severity:Severe FDA (Devices)·Z-1064-2017·Announced 2017-02-01

Villa Radiology Systems Recalls Apollo X-Ray Systems Due to Injury Risk

Villa Radiology Systems LLC is recalling 66 Apollo multi-function x-ray systems after an injury incident involving inadvertent movement activation and delayed emergency stop response.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a reported injury incident, meeting the rubric criteria for a Severe rating.

Plain-English summary

Villa Radiology Systems LLC is recalling 66 units of the Apollo multi-function x-ray system, including models 9784000131, 9784000231, 9784020131, 9784020231, 9784100231, 9784120131, 9784120231, and 9784130131. These devices are capable of routine radiograph and general fluoroscopy procedures. The recall is classified as Class II by the FDA.

The recall follows an injury incident caused by a chain of four faults. First, an injured person overcame a physical barrier (a tabletop support arm approximately 60 cm high) to access a prohibited area not intended as a working position. Second, the device labeling and instructions for use did not explicitly exclude this prohibited area. Third, the movement was activated inadvertently and continuously, and it was not released, despite requiring continuous activation. Fourth, there was a delayed activation of the emergency stop.

The affected units were distributed in the United States, including in Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Iowa, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, New Jersey, New York, Ohio, Pennsylvania, Puerto Rico, Tennessee, Texas, Utah, and Wisconsin. Users should contact Villa Radiology Systems LLC for further instructions on the recall.

The recalled product

Product: Apollo: Models: 9784000131, 9784000231, 9784020131, 9784020231, 9784100231, 9784120131, 9784120231, 9784130131 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures.
Manufacturer: Villa Radiology Systems LLC
Category: Medical Device — X-Ray Systems
Hazard: injury
inadvertent-activation
delayed-emergency-stop
Affected units: 66

Distribution

Distributed in 26 states:

Part of a larger recall action

This product is one of 4 recalled by Villa Radiology Systems LLC 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 4 products in this recall →

Same manufacturer · Villa Radiology Systems LLC

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Villa Radiology Systems Recalls Apollo DRF X-Ray Systems Due to Injury Risk
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Villa Radiology Systems Recalls Apollo EZ X-Ray Systems Due to Injury Risk
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Same hazard · injury