CLASS II ONGOING Device recall · Reported 1 Feb 2017 · FDA Enforcement Report
Juno DRF recalled by Villa Radiology Systems
Villa Radiology Systems is recalling Juno DRF, distributed in 24 states. The recall was initiated on 19 Feb 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1063-2017
- FDA event ID
- 73459
- Recalling firm
- Villa Radiology Systems, Oxford, CT
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 19 Feb 2016
- FDA classified
- 20 Jan 2017
- Reported
- 1 Feb 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 19 Feb 2016 | Recall initiated by company | |
| 20 Jan 2017 | Classified by FDA | +336 days |
| 1 Feb 2017 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Juno DRF; Model: 709020 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures.
Where it was distributed
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
AlabamaArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaFloridaIowaIllinoisLouisianaMassachusettsMarylandMichiganMinnesotaMissouriMississippiNew JerseyNew YorkPennsylvaniaPuerto Rico
Questions about this recall
Is Juno DRF recalled?
Yes. Villa Radiology Systems recalled Juno DRF on 19 Feb 2016. The recall is Class II and its status is Ongoing. Recall number Z-1063-2017.
Why was it 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 lots are affected?
10110770 11030805 11030806 11070845 11070848 11070849 11090864 11110900 12020978 12020982 12030999 12041003 12061014 12061018 12061020 12081040 12091074 12101104 12121186 12121187 13031215 13101263 14021301 14031313 14041321 14051332 14071353 14081359 14091368 14091371 14121400 14121403 15021426 15031440 15041444 15091473 15091478 15101484 15101487
Where was it sold?
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
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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