FDA Medical Device Recalls (openFDA)
Villa Sistemi Medicali S.P.A.: Apollo; Models: 9784000131 9784000231 9784020131 9784020231 9784100231 9784120131 9784120231 9784130131 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures.
- Recall number
- Z-1428-2017
- Recalling firm
- Villa Sistemi Medicali S.P.A.
- Product
- Apollo; Models: 9784000131 9784000231 9784020131 9784020231 9784100231 9784120131 9784120231 9784130131 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 Numbers: 06100127 06110138 07010149 07020158 07020163 07020165 07030171 07040206 09010566 09090605 10100752 11100873 15041446
- 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