Villa Radiology Systems Recalls Apollo EZ X-Ray Systems Due to Injury Risk
Villa Radiology Systems LLC is recalling 66 Apollo EZ multi-function x-ray systems because a chain of faults caused an injury to a user.
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 meets the rubric criteria for 'significant injury reports' under the Severe (4) classification.
Plain-English summary
Villa Radiology Systems LLC is recalling 66 units of the Apollo EZ multi-function x-ray system, model 9784152036. These devices 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 EZ: Model: 9784152036 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)
- 13101261
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.
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