CLASS II ONGOING Device recall · Reported 8 Jan 2020 · FDA Enforcement Report

Juno DRF recalled by Villa Sistemi Medicali S.P.A

Villa Sistemi Medicali is recalling Juno DRF, distributed nationwide in the US. The recall was initiated on 4 Nov 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Numbers: 10110770 11030805 11030806 11070845 11070848 11070849 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 15121505 16011512 16021514 16021517 16021518 16041533 16121595 19011923

Quantity recalled46

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-0763-2020
FDA event ID: 84309
Recalling firm: Villa Sistemi Medicali, Buccinasco, N/A
Classification: Class II
Status: Ongoing
Recall initiated: 4 Nov 2019
FDA classified: 31 Dec 2019
Reported: 8 Jan 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Foreign Material
Device type: Imaging Equipment

Timeline

4 Nov 2019	Recall initiated by company
31 Dec 2019	Classified by FDA	+57 days
8 Jan 2020	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

An amendment to the IFU and Service Manual is being issued to prescribe the replacement of the angulation chain after 8 years of service of the of the unit. After testing, it was found that due to metal fatigue under sever workload conditions, the angulation chain might fail before the expected lifetime of 10 years.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

Juno DRF, Model Number 709020 - Product Usage: General. multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures.

Where it was distributed

US Nationwide distribution in the states of AL, AZ, CA, CO, CT, DC, FL, IA, IL, IN, LA, MA, MD, MI, MN, MO, MS, NJ, NY, OH, OK, PA, TN, TX, UT, and Puerto Rico.

Nationwide Alabama Arizona California Colorado Connecticut District of Columbia Florida Iowa Illinois Indiana Louisiana Massachusetts Maryland Michigan Minnesota Missouri Mississippi New Jersey New York Ohio

Questions about this recall

Why was it recalled?

Which lots are affected?

Serial Numbers: 10110770 11030805 11030806 11070845 11070848 11070849 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 15121505 16011512 16021514 16021517 16021518 16041533 16121595 19011923

Where was it sold?

US Nationwide distribution in the states of AL, AZ, CA, CO, CT, DC, FL, IA, IL, IN, LA, MA, MD, MI, MN, MO, MS, NJ, NY, OH, OK, PA, TN, TX, UT, and Puerto Rico.

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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 84309

Reported	Class	Recall	Company	Reason	Where
8 Jan 2020	CLASS II	Apollo EZ recalled by Villa Sistemi Medicali S.P.A	Villa Sistemi Medicali	Foreign Material	Nationwide
8 Jan 2020	CLASS II	Apollo DRF recalled by Villa Sistemi Medicali S.P.A	Villa Sistemi Medicali	Foreign Material	Nationwide
8 Jan 2020	CLASS II	Apollo, Model Numbers 9784100231, 9784120131, 9784130131 - Product recalled	Villa Sistemi Medicali	Foreign Material	Nationwide

More recalls from Villa Sistemi Medicali

All 8

Reported	Class	Recall	Company	Reason	Where
8 Jan 2020Device	CLASS II	Apollo, Model Numbers 9784100231, 9784120131, 9784130131 - Product recalled	Villa Sistemi Medicali	Foreign Material	Nationwide
8 Jan 2020Device	CLASS II	Apollo DRF recalled by Villa Sistemi Medicali S.P.A	Villa Sistemi Medicali	Foreign Material	Nationwide
8 Jan 2020Device	CLASS II	Apollo EZ recalled by Villa Sistemi Medicali S.P.A	Villa Sistemi Medicali	Foreign Material	Nationwide
15 Mar 2017Device	CLASS II	Apollo EZ recalled by Villa Sistemi Medicali S.P.A	Villa Sistemi Medicali	Other	Nationwide
15 Mar 2017Device	CLASS II	Apollo DRF recalled by Villa Sistemi Medicali S.P.A	Villa Sistemi Medicali	Other	Nationwide

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