Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported February 1, 2017
Apollo DRF: Model: 9784220831 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures.
The analysis showed that the incident was caused by a chain of four faults: 1.) The injured person overcame a physical barrier (the tabletop support arm. height ca. 60 em) to acc…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Villa Radiology Systems LLC recalled Apollo DRF: Model: 9784220831 Multi-function x-ray systems capable of routine radiogra… - a moderate-severity action.
Apollo DRF: Model: 9784220831 Multi-function x-ray systems capable of routine radiogra… was recalled by Villa Radiology Systems LLC in February 1, 2017. Reason: The analysis showed that the incident was caused by a chain of four faults: 1.) The injured person overcame …. Check the official notice for the remedy. Verify recall #Z-1065-2017 with the FDA Devices before acting.
The recall
Villa Radiology Systems LLC issued this moderate-severity FDA Devices recall-The analysis showed that the incident was caused by a chain of four faults: 1.) The injured person overcame ….
- Moderate
- severity level
- Class II
- classification
- February 1, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1065-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1065-2017) was formally reported on February 1, 2017, with the manufacturer initiating the action on February 19, 2016. It is classified under Moderate severity (Class II), with a current status of Ongoing. Villa Radiology Systems LLC is listed as the recalling firm, operating out of Oxford, CT. Federal records list the affected scope as 66 distributed in US.
The documented reason for this recall is: The analysis showed that the incident was caused by a chain of four faults: 1.) The injured person overcame a physical barrier (the tabletop support arm. height ca. 60 em) to access a prohibited area not intended as a … Distribution data in the federal record shows the product reached: AL AZ CA CO CT DC FL IA IL IN LA MA MD MI MN MO MS NJ NY OH PA Puerto Rico TN TX UT WI. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
66 distributed in US
Related Recalls
6
3 from same agency
Product description
Apollo DRF: Model: 9784220831 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures.
Reason for recall
The analysis showed that the incident was caused by a chain of four faults: 1.) The injured person overcame a physical barrier (the tabletop support arm. height ca. 60 em) to access a prohibited area not intended as a working position. 2) The directions for use (device labeling and instructions for use) did not contain an explicit exclusion of the prohibited area. 3.) The movement was activated inadvertently and continuously. and it was not released (the movement requires continuous activation). 4.) Delayed activation of the emergency stop.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1065-2017 |
| Date reported | February 1, 2017 |
| Date initiated | February 19, 2016 |
| Recalling firm | Villa Radiology Systems LLC |
| Firm location | Oxford, CT |
| Affected scope | 66 distributed in US |
| Distribution | AL AZ CA CO CT DC FL IA IL IN LA MA MD MI MN MO MS NJ NY OH PA Puerto Rico TN TX UT WI |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1065-2017) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Apollo DRF: Model: 9784220831 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures.. Recalled by Villa Radiology Systems LLC. Units affected: 66 distributed in US.
Why was this product recalled? ▼
The analysis showed that the incident was caused by a chain of four faults: 1.) The injured person overcame a physical barrier (the tabletop support arm. height ca. 60 em) to access a prohibited area not intended as a working position. 2) The directions for use (device labeling and instructions for use) did not contain an explicit exclusion of the prohibited area. 3.) The movement was activated inadvertently and continuously. and it was not released (the movement requires continuous activation). 4.) Delayed activation of the emergency stop.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 1, 2017. Severity: Moderate. Recall number: Z-1065-2017.
Where was the recalled product distributed? ▼
Distribution: AL AZ CA CO CT DC FL IA IL IN LA MA MD MI MN MO MS NJ NY OH PA Puerto Rico TN TX UT WI.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1065-2017) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported February 1, 2017. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.