FDA Device recall Z-0765-2020
Apollo DRF, Model Number 9784220831 - Product Usage: The remote controlled table Apollo DRF is an X-ray equipment that allows to perform ge…
- FDA Device
- Class II
- ongoing
- Published 2020-01-08
On 2020-01-08 the FDA classified a Class II recall of Apollo DRF, Model Number 9784220831 - Product Usage: The remote controlled table Apollo DRF is an X-ray equipment that allows to perform ge… 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-0765-2020 |
| 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 DRF, Model Number 9784220831 - Product Usage: The remote controlled table Apollo DRF is an X-ray equipment that allows 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.
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: 08090531 09090591 10040680 15051450 11020798 17011602 17041639 |
|---|
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-0765-2020%22
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