The Recall Desk
SevereFDA (Devices)·Z-1430-2017·Announced 2017-03-15

Villa Sistemi Medicali Recalls Apollo EZ X-Ray Systems Due to Footrest Detachment

Villa Sistemi Medicali is recalling 65 Apollo EZ 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 injury (patient fall) caused by a structural defect in the medical device.

Plain-English summary

Villa Sistemi Medicali S.P.A. is recalling 65 units of the Apollo EZ multi-function x-ray system (Model 9784152036). These devices are used for routine radiographs and general fluoroscopy procedures. The recall affects serial number 13101261.

The recall was initiated because the footrest of the device detached from the table top while a patient was positioned on the table and the table was moving from a vertical position. This mechanical failure caused the patient to fall from the table.

The affected devices were distributed nationwide 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, Pennsylvania, Puerto Rico, Tennessee, Texas, Utah, and West Virginia. Users of these devices should contact the manufacturer for further instructions.

The recalled product

Product
Apollo EZ; Model: 9784152036 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures
Affected units
65

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Serial Number: 13101261

Distribution

Distributed nationwide across the United States.

The notice also names 24 states specifically:

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.

See all 4 products in this recall →