Villa Radiology Systems Recalls Apollo DRF X-Ray Systems Due to Injury Risk
Villa Radiology Systems LLC is recalling 66 Apollo DRF multi-function x-ray systems because a chain of faults led to an injury involving inadvertent movement activation.
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 source text explicitly states that an 'injured person' was involved in the incident, which aligns with the rubric criterion for 'significant injury reports' under a Severe (Score 4) classification.
Plain-English summary
Villa Radiology Systems LLC is recalling 66 units of the Apollo DRF multi-function x-ray system, model 9784220831. These systems are capable of routine radiograph and general fluoroscopy procedures. The recall affects units distributed across 26 states and Puerto Rico.
The recall was initiated after an analysis determined that an incident was caused by a chain of four faults. The injured person overcame a physical barrier to access a prohibited area not intended as a working position. The device labeling and instructions for use did not explicitly exclude this prohibited area. Additionally, the movement was activated inadvertently and continuously without being released, and the emergency stop was activated with a delay.
Consumers and healthcare facilities with these devices should contact Villa Radiology Systems LLC for further instructions on the recall and corrective actions.
The recalled product
- Product
- Apollo DRF: Model: 9784220831 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures.
- Manufacturer
- Villa Radiology Systems LLC
- Category
- Medical Device — X-Ray Systems
- Affected units
- 66
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 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 →Related recalls
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