Apollo — Class II medical device recall Z-0764-2020
Ongoing recall by Villa Sistemi Medicali S.P.A., reported 2020-01-08, distributed nationwide. An amendment to the IFU and Service Manual is being issued to prescribe the replacement of the angulation chai
| Recall number | Z-0764-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Villa Sistemi Medicali S.P.A., Buccinasco, N/A, Italy |
| Recall initiated | 2019-11-04 |
| Classified | 2019-12-31 |
| Reported by FDA | 2020-01-08 |
| Distributed | Nationwide (US) |
| Quantity | 3 |
| Serial numbers | 08020473, 11100873, 15041446 |
| Model numbers | 9784100231, 9784120131, 9784130131 |
Product
Apollo, Model Numbers 9784100231, 9784120131, 9784130131 - Product Usage: Apollo table is a remote controlled X-ray system suitable for radiography and fluoroscopy examinations. The system is stationary mounted. The movements of the table and the tube stand are motorized and remotely controlled. Medical purpose is the diagnosis, visualization and documentation of various human diseases or injuries.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0764-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.