Z-0764-2020Class II

Apollo, Model Numbers 9784100231, 9784120131, 9784130131 -

Name: Z-0764-2020 Apollo, Model Numbers 9784100231, 9784120131, 9784130131 -
Creator: Villa Sistemi Medicali S.P.A.
Published: 2019-11-04
License: https://open.fda.gov/license/

Villa Sistemi Medicali S.p.A. / initiated 2019-11-04 / Open, Classified / root cause: design

FDA source

Villa Sistemi Medicali S.P.A. began a recall of Apollo, Model Numbers 9784100231, 9784120131, 9784130131 - Product Usage: Apollo table is a remote controlled X-ray system suitable for radiography and... on 2019-11-04. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0764-2020
Classification: Class II
Status: Open, Classified
Initiated: 2019-11-04
Posted: 2019-12-31
Recalling firm: Villa Sistemi Medicali S.p.A.
Product: Apollo, Model Numbers 9784100231, 9784120131, 9784130131 - Product Usage: Apollo table is a remote controlled X-ray system suitable for radiography and fluoroscopy examinations. The system is stationary mounted. The movements of the table and the tube stand are motorized and remotely controlled. Medical purpose is the diagnosis, visualization and documentation of various human diseases or injuries.
Product code: KXJ Table, Radiologic
Reason for recall: 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.
Root cause tag: design
FDA root cause: Device Design
Action: Urgent Field Safety Notice notification letters dated 10/23/19 were sent to customers. Action to be taken by the customer/user: The user shall take note of amendment/reinforcement of Instructions for Use (IFU) and Service Manual, attached to this FN and, if it is the case, request a service technician to do the periodic preventive maintenance the user shall replace the attached pages in the User Manual and in the Service Manual, prescribing the periodic replacement of the angulation chain. Fill the table present in the addendum; In the cell "Next replacement date" write the date adding 8 years to the replacement date. All the examinations performed on the device before the recall remain valid. The IFU and the Service Manual need to be amended to prescribe the replacement of the angulation chain after 8 years of service life of the unit. This notice needs to be passed to all users of Apollo, Apollo DRF, Apollo EZ and to all those who need to be aware within your organisation or to any organisation where the potentially affected devices have been transferred.
Quantity in commerce: 3
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, OH, OK, PA, TN, TX, UT, and Puerto Rico.
Product codes and lots: Serial Numbers: 08020473 11100873 15041446

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0764-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0763-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-01-08	2019-12-31
Z-0764-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-01-08	2019-12-31
Z-0765-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-01-08	2019-12-31
Z-0766-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-01-08	2019-12-31

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)