Villa Sistemi Medicali Recalls Apollo X-Ray Systems Due to Footrest Detachment
Villa Sistemi Medicali is recalling 65 Apollo multi-function x-ray systems because the footrest detached from the table, causing a patient to fall.
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 is classified as FDA Class II and involves a reported patient fall from the device, which constitutes a significant injury report.
Plain-English summary
Villa Sistemi Medicali S.P.A. is recalling 65 units of the Apollo multi-function x-ray system. The affected models are 9784000131, 9784000231, 9784020131, 9784020231, 9784100231, 9784120131, 9784120231, and 9784130131. These devices are used for routine radiographs and general fluoroscopy procedures.
The recall was initiated after a patient fell from the table because the footrest detached from the tabletop while the patient was positioned on the table and the table was moving from a vertical position. The agency has classified this as a Class II recall.
The affected devices were distributed nationwide in the United States, including in Alabama, Arizona, California, Colorado, Connecticut, the District of Columbia, Florida, Iowa, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, New Jersey, New York, Pennsylvania, Puerto Rico, Tennessee, Texas, Utah, and West Virginia. Specific serial numbers for the affected units are listed in the official recall notice.
The recalled product
- Product
- Apollo; Models: 9784000131 9784000231 9784020131 9784020231 9784100231 9784120131 9784120231 9784130131 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures.
- Manufacturer
- Villa Sistemi Medicali S.P.A.
- Category
- Medical Device — X-Ray Systems
- Affected units
- 65
Distribution
Part of a larger recall action
This product is one of 4 recalled by Villa Sistemi Medicali S.P.A. 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.
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