CLASS II Device recall · Reported 15 Mar 2017 · FDA Enforcement Report
Apollo DRF recalled by Villa Sistemi Medicali S.P.A
Villa Sistemi Medicali S.P.A is recalling Apollo DRF, distributed nationwide in the US. The recall was initiated on 27 Dec 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-1429-2017
- FDA event ID
- 76367
- Recalling firm
- Villa Sistemi Medicali S.P.A, Buccinasco, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Dec 2016
- FDA classified
- 9 Mar 2017
- Reported
- 15 Mar 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 27 Dec 2016 | Recall initiated by company | |
| 9 Mar 2017 | Classified by FDA | +72 days |
| 15 Mar 2017 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Patient fell from the table because the footrest of the device detached from the table top while the patient was positioned on the table and table was moving from vertical position.
Product as listed by the FDA
Apollo DRF; Model: 9784220831 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, PA, Puerto Rico, TN, TX, UT, and W.I
Nationwide AlabamaArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaFloridaIowaIllinoisIndianaLouisianaMassachusettsMarylandMichiganMinnesotaMissouriMississippiNew JerseyNew YorkPennsylvania
Questions about this recall
Why was it recalled?
Patient fell from the table because the footrest of the device detached from the table top while the patient was positioned on the table and table was moving from vertical position.
Which lots are affected?
08090531 09090591 10040680 15051450 11020798
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, PA, Puerto Rico, TN, TX, UT, and W.I
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.
Other products in this recall event
3 other products · FDA event 76367This product is part of a recall event; the main page for the event is Juno DRF recalled by Villa Sistemi Medicali S.P.A.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Juno DRF recalled by Villa Sistemi Medicali S.P.A | Villa Sistemi Medicali S.P.A | Other | Nationwide | |
| CLASS II | Apollo; Models: 9784000131 recalled by Villa Sistemi Medicali S.P.A | Villa Sistemi Medicali S.P.A | Other | Nationwide | |
| CLASS II | Apollo EZ recalled by Villa Sistemi Medicali S.P.A | Villa Sistemi Medicali S.P.A | Other | Nationwide |
More recalls from Villa Sistemi Medicali S.P.A
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Apollo, Model Numbers 9784100231, 9784120131, 9784130131 - Product recalled | Villa Sistemi Medicali S.P.A | Foreign Material | Nationwide |
| Device | CLASS II | Apollo DRF recalled by Villa Sistemi Medicali S.P.A | Villa Sistemi Medicali S.P.A | Foreign Material | Nationwide |
| Device | CLASS II | Apollo EZ recalled by Villa Sistemi Medicali S.P.A | Villa Sistemi Medicali S.P.A | Foreign Material | Nationwide |
| Device | CLASS II | Juno DRF recalled by Villa Sistemi Medicali S.P.A | Villa Sistemi Medicali S.P.A | Foreign Material | Nationwide |
| Device | CLASS II | Apollo EZ recalled by Villa Sistemi Medicali S.P.A | Villa Sistemi Medicali S.P.A | Other | Nationwide |
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| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Ultrasound Breast Pack recalled | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Alphenix Models Infx-8000C Infx-8000F Infx-8000V This device recalled | Canon Medical System, USA | Other | Nationwide |
| Device | CLASS II | Merge PACS and Merge OrthoPACS recalled by Merge Healthcare | Merge Healthcare | Labeling Errors | Nationwide |
| Device | CLASS II | Philips Azurion recalled by Philips Medical Systems | Philips Medical Systems Nederland B.v | Lead & Heavy Metals |