The Recall Desk
SevereFDA (Devices)·Z-1429-2017·Announced 2017-03-15

Apollo DRF X-ray Systems Recalled Due to Footrest Detachment Hazard

Villa Sistemi Medicali is recalling 65 Apollo DRF x-ray systems because the footrest can detach, causing patients to fall from the table.

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 involves a structural defect in a medical device that resulted in a patient falling, which constitutes a significant injury risk and aligns with the 'Severe' criteria for structural defects and injury reports.

Plain-English summary

Villa Sistemi Medicali S.P.A. is recalling 65 units of the Apollo DRF x-ray system, Model 9784220831. These are general, multi-function x-ray systems used for routine radiographs and general fluoroscopy procedures. The recall covers devices distributed nationwide in specific states and Puerto Rico.

The recall is being conducted because the footrest of the device can detach from the table top while a patient is positioned on the table and the table is moving from a vertical position. This defect has resulted in a patient falling from the table.

Healthcare facilities and consumers with these devices should stop using them and contact the recalling firm for instructions on repair or replacement. The affected serial numbers are 08090531, 09090591, 10040680, 15051450, and 11020798.

The recalled product

Product
Apollo DRF; Model: 9784220831 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)

  • 08090531 09090591 10040680 15051450 11020798

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 →