FDA Medical Device Recalls (openFDA)
Villa Sistemi Medicali S.P.A.: Apollo EZ; Model: 9784152036 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures
- Recall number
- Z-1430-2017
- Recalling firm
- Villa Sistemi Medicali S.P.A.
- Product
- Apollo EZ; Model: 9784152036 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures
- Status
- Terminated
- Initiated
- 2016-12-27
- Posted
- not on file
- Terminated
- 2021-03-09
- 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.
- Root cause
- Nonconforming Material/Component
- Action
- Customers were notified of the recall via DHL or similar mail service. The letter identified the affected product, problem and actions to be taken.
- Quantity
- 65 devices in total
- Distribution
- 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, PA, Puerto Rico, TN, TX, UT, and W.I
- Lot, serial or model codes
- Serial Number: 13101261
- 510(k) numbers
- ["K050190"]
- PMA numbers
- not on file
- Product code
- KXJ
- Firm FEI
- 3002808461
- Firm city
- Buccinasco
- Firm state
- not on file
- Firm country
- Italy
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28