Recall Z-1430-2017— Villa Sistemi Medicali S.P.A.
Class II · Terminated
Class II FDA medical device recall by Villa Sistemi Medicali S.P.A., initiated 2016-12-27, terminated 2021-03-09. It names one FDA 510(k) clearance: K050190. Product: Apollo EZ; Model: 9784152036 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures. Reason: 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..
- Recalling firm
- Villa Sistemi Medicali S.P.A.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-12-27
- Terminated
- 2021-03-09
- Firm location
- Buccinasco, N/A, Italy
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Apollo EZ; Model: 9784152036 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.