Apollo EZ

• EUDAMED Basic UDI-DI 805773712FT2209C registered 28 Jul 2025 Active
• FDA 510(k) K050190 decided 25 Mar 2005 Active
• FDA GUDID UDI-DI 08057737120213 listed 24 Sep 2016 Listed

• 4 recalls, same reason

  • Ongoing Z-0763-2020 FDA Class II ·initiated 4 Nov 2019
  • Ongoing Z-0765-2020 FDA Class II ·initiated 4 Nov 2019
  • Ongoing Z-0764-2020 FDA Class II ·initiated 4 Nov 2019
  • Ongoing Z-0766-2020 FDA Class II ·initiated 4 Nov 2019

  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.

• 4 recalls, same reason

  • Ongoing Z-1063-2017 FDA Class II ·initiated 19 Feb 2016
  • Ongoing Z-1064-2017 FDA Class II ·initiated 19 Feb 2016
  • Ongoing Z-1065-2017 FDA Class II ·initiated 19 Feb 2016
  • Ongoing Z-1066-2017 FDA Class II ·initiated 19 Feb 2016

  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.

• 4 recalls, same reason

  • Terminated Z-1429-2017 FDA Class II ·initiated 27 Dec 2016
  • Terminated Z-1427-2017 FDA Class II ·initiated 27 Dec 2016
  • Terminated Z-1430-2017 FDA Class II ·initiated 27 Dec 2016
  • Terminated Z-1428-2017 FDA Class II ·initiated 27 Dec 2016

  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.

• • Terminated Z-1079-2015 FDA Class II ·initiated 14 Dec 2014

  The system does not provide the appropriate audible signal, permanent activation, and manual override, although the system is in high-level control functionality

• • Terminated Z-2160-2013 FDA Class II ·initiated 2 Aug 2013

  It has been discovered that the Air Kerma rate information is inconsistent in Continuous Fluoro modes 30x30 (12"x12") and 15x15 (6"x6). This could result in a deviation of the displayed values of Air Kerma Rate and Cumulated Air Kerma from the actual values greater then +/-35% and then in a failure to comply with the requirements of 21 CFR 1020.32(k)(6

• • Terminated Z-0702-2013 FDA Class II ·initiated 13 Dec 2012 ·on shared 510(k) K050190

  Values of fluoroscopy time, Air Kerma Rate and Cumulated Air Kerma may not be displayed "at the fluoroscopist's working position" as per 21 CFR 1003.21

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

1. 24 Sep 2016 Listed FDA GUDID 08057737120213
2. 27 Dec 2016 Recall initiated FDA recalls Z-1429-2017
3. 27 Dec 2016 Recall initiated FDA recalls Z-1427-2017
4. 27 Dec 2016 Recall initiated FDA recalls Z-1430-2017
5. 27 Dec 2016 Recall initiated FDA recalls Z-1428-2017
6. 4 Nov 2019 Recall initiated FDA recalls Z-0763-2020
7. 4 Nov 2019 Recall initiated FDA recalls Z-0765-2020
8. 4 Nov 2019 Recall initiated FDA recalls Z-0764-2020
9. 4 Nov 2019 Recall initiated FDA recalls Z-0766-2020
10. 28 Jul 2025 Registered EUDAMED 805773712FT2209C

8 earlier events are in the sections above.

Trade name

Apollo EZ EUDAMED

Villa Sistemi Medicali GUDID

Generic name

Stationary general-purpose fluoroscopic x-ray system, analogue

Device name

Apollo

Model / reference

9784NB0031 EUDAMED

Apollo EZ GUDID

Primary DI / UDI-DI

08057737120213

Basic UDI-DI

805773712FT2209C

Direct marketing DI

08057737120213

510(k) Number

K050190 ↗

FDA product code

KXJ, IXL, KPW

EMDN code

Z11030701 Conventional remote control tables

GMDN term

Stationary general-purpose fluoroscopic x-ray system, analogue

Device class

Class IIb EUDAMED

Class II GUDID

Regulation number

892.1980, 892.1670, 892.1610

EU registration type

Standard device

EU market of registration

Italy

GUDID distribution status

In Commercial Distribution

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

EUDAMED SRN

IT-MF-000016860

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  CE/MDR GUDID on market

• Apollo DRF

  Class IIb

  CE/MDR

See all devices from Villa Sistemi Medicali S.P.A. →