FDA Device recall Z-0764-2020
Apollo, Model Numbers 9784100231, 9784120131, 9784130131 - Product Usage: Apollo table is a remote controlled X-ray system suitable for rad…
- FDA Device
- Class II
- ongoing
- Published 2020-01-08
On 2020-01-08 the FDA classified a Class II recall of Apollo, Model Numbers 9784100231, 9784120131, 9784130131 - Product Usage: Apollo table is a remote controlled X-ray system suitable for rad… by Villa Sistemi Medicali S P A, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0764-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-11-04 |
| Published | 2020-01-08 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Villa Sistemi Medicali S P A |
| Distribution | US |
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
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.
Identifiers
| code_info | Serial Numbers: 08020473 11100873 15041446 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0764-2020%22
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