CLASS II ONGOING Device recall · Reported 8 Jan 2020 · FDA Enforcement Report
Apollo EZ recalled by Villa Sistemi Medicali S.P.A
Villa Sistemi Medicali is recalling Apollo EZ, 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
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-0766-2020
- 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
Apollo EZ, Model Number 9784152036 - Product Usage: The Apollo EZ remote-controlled table is X-ray equipment that can be used to perform general radiographic and fluoroscopic examinations. The system is a fixed position type. The movements of the table and tube support are motorized and remote-controlled. Medical purpose is the diagnosis, visualization and documentation of various human diseases or injuries.
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 AlabamaArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaFloridaIowaIllinoisIndianaLouisianaMassachusettsMarylandMichiganMinnesotaMissouriMississippiNew JerseyNew YorkOhio
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Serial Numbers: 13101261
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 84309This 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 | Foreign Material | Nationwide | |
| CLASS II | Apollo DRF recalled by Villa Sistemi Medicali S.P.A | Villa Sistemi Medicali | Foreign Material | Nationwide | |
| 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 |
|---|---|---|---|---|---|
| Device | CLASS II | Apollo, Model Numbers 9784100231, 9784120131, 9784130131 - Product recalled | Villa Sistemi Medicali | Foreign Material | Nationwide |
| Device | CLASS II | Apollo DRF recalled by Villa Sistemi Medicali S.P.A | Villa Sistemi Medicali | Foreign Material | Nationwide |
| Device | CLASS II | Juno DRF recalled by Villa Sistemi Medicali S.P.A | Villa Sistemi Medicali | Foreign Material | Nationwide |
| Device | CLASS II | Apollo EZ recalled by Villa Sistemi Medicali S.P.A | Villa Sistemi Medicali | Other | Nationwide |
| Device | CLASS II | Apollo DRF recalled by Villa Sistemi Medicali S.P.A | Villa Sistemi Medicali | Other | Nationwide |
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