Z-1064-2017Class II

Apollo: Models: 9784000131, 9784000231, 9784020131, 9784020231, 9784100231, 9784120131, 9784120231...

Name: Z-1064-2017 Apollo: Models: 9784000131, 9784000231, 9784020131, 9784020231, 9784100231, 9784120131, 9784120231...
Creator: Villa Radiology Systems LLC
Published: 2016-02-19
License: https://open.fda.gov/license/

Acteon, Inc. / initiated 2016-02-19 / Open, Classified / root cause: design

FDA source

Villa Radiology Systems LLC began a recall of Apollo: Models: 9784000131, 9784000231, 9784020131, 9784020231, 9784100231, 9784120131, 9784120231, 9784130131 Multi-function x-ray systems capable of routine... on 2016-02-19. FDA classified it as Class II and gives the reason as "The analysis showed that the incident was caused by a chain of four faults: 1.) The injured person overcame a physical barrier (the tabletop support arm. height ca. 60 em) to access a prohibited area not intended as a...". 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-1064-2017
Classification: Class II
Status: Open, Classified
Initiated: 2016-02-19
Posted: 2017-01-20
Recalling firm: Acteon, Inc.
Product: Apollo: Models: 9784000131, 9784000231, 9784020131, 9784020231, 9784100231, 9784120131, 9784120231, 9784130131 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures.
Product code: KXJ Table, Radiologic
Reason for recall: The analysis showed that the incident was caused by a chain of four faults: 1.) The injured person overcame a physical barrier (the tabletop support arm. height ca. 60 em) to access a prohibited area not intended as a working position. 2) The directions for use (device labeling and instructions for use) did not contain an explicit exclusion of the prohibited area. 3.) The movement was activated inadvertently and continuously. and it was not released (the movement requires continuous activation). 4.) Delayed activation of the emergency stop.
Root cause tag: design
FDA root cause: Device Design
Action: Consignees were notified of the recall via letter starting on 2/19/16. The letter explains the issue and actions to be taken by the consignee and manufacturer.
Quantity in commerce: 66 distributed in US
Distribution: AL AZ CA CO CT DC FL IA IL IN LA MA MD MI MN MO MS NJ NY OH PA Puerto Rico TN TX UT WI
Product codes and lots: 06040078 07030172 06090116 06110138 07010149 07020158 07020162 07020163 07020165 07030168 07030171 07040206 09090605 10100752 06060086 06100127 09010566 08020473 11100873 15041446

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1064-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1063-2017	Class II	Ongoing	Voluntary: Firm initiated	2017-02-01	2017-01-20
Z-1064-2017	Class II	Ongoing	Voluntary: Firm initiated	2017-02-01	2017-01-20
Z-1065-2017	Class II	Ongoing	Voluntary: Firm initiated	2017-02-01	2017-01-20
Z-1066-2017	Class II	Ongoing	Voluntary: Firm initiated	2017-02-01	2017-01-20

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)