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.
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 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
- Manufacturer
- Villa Sistemi Medicali S.P.A.
- Category
- Medical Device — X-ray Systems
- 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
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 →Related recalls
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Similar recalls
- SevereVilla Radiology Systems Recalls Apollo DRF X-Ray Systems Due to Injury Risk
FDA (Devices) · 2017-02-01
- HighVilla Sistemi Medicali Recalls Apollo DRF X-ray Tables Due to Chain Failure
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- SevereVilla Radiology Systems Recalls Apollo X-Ray Systems Due to Injury Risk
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