Z-1428-2017Class II

Apollo; Models: 9784000131 9784000231 9784020131 9784020231 9784100231 9784120131 9784120231 9784130131

Name: Z-1428-2017 Apollo; Models: 9784000131 9784000231 9784020131 9784020231 9784100231 9784120131 9784120231 9784130131
Creator: Villa Sistemi Medicali S.P.A.
Published: 2016-12-27
License: https://open.fda.gov/license/

Villa Sistemi Medicali S.p.A. / initiated 2016-12-27 / Terminated / root cause: manufacturing process

FDA source

Villa Sistemi Medicali S.P.A. began a recall of Apollo; Models: 9784000131 9784000231 9784020131 9784020231 9784100231 9784120131 9784120231 9784130131 Product Usage: General, multi-function x-ray systems... on 2016-12-27. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1428-2017
Classification: Class II
Status: Terminated
Initiated: 2016-12-27
Posted: 2017-03-09
Terminated: 2021-03-09
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.
Product code: KXJ Table, Radiologic
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 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
Product codes and lots: Serial Numbers: 06100127 06110138 07010149 07020158 07020163 07020165 07030171 07040206 09010566 09090605 10100752 11100873 15041446

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1428-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1427-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-15	2017-03-09
Z-1428-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-15	2017-03-09
Z-1429-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-15	2017-03-09
Z-1430-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-15	2017-03-09

Product code KXJ

K050190Class IIApolloVilla Sistemi Medicali S.P.A. / cleared 2005-03-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)