ACTEON
SOPRO · Model SYSTEME PSPIX WIN MAC (Only) · UDI-DI 03760278260434
MUH
Prescription
1
510(k) clearances
65
Adverse events
9
Recalls
90
Facilities
Description
"The PSPIX system is a laser X-ray device designed to digitize, display and erase intra oral x-ray images stored in imaging plates (IPs) - also known as phosphor plates."
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-04-29 | KaVo Dental Technologies LLC | The sensor's look up calibration files were incorrectly programmed during manufacturing, which can result in the reduction of image quality. |
| 2015-08-05 | Villa Radiology Systems LLC | It has been discovered that due to lack of information accompanying documents the product fails to comply with 21CfR 1020.33(c),1020.33(d),1020.33(g),and 1020.330). |
| 2015-01-08 | Carestream Health, Inc. | Units device head descended unexpectedly |
| 2015-01-08 | Carestream Health, Inc. | Units device head descended unexpectedly |
| 2014-09-04 | Midmark Corp dba Progeny Inc | Failure of the primary collimator may result in unintentional movement of the device. The unintentional movement will not result in the generation of an error message. |
| 2013-09-20 | Midmark Corp dba Progeny Inc | An error was identified in the Real Time Controller (RTC) firmware versions 3.0, 3.1, 3.2, and 3.3 used in Vantage Panoramic X-Ray systems. The error may cause the column of the Va |
| 2009-03-06 | Gendex Dental Systems | There is a compatibility issue when the VixWin Platinum versions 1.0/1.1/1.2 software is used in conjunction with Easy Dental, PracticeWorks, EagleSoft and SoftDent practice manage |
| 2009-01-08 | Imaging Sciences International, LLC | faulty calibration |
| 2008-03-19 | Imaging Sciences Intl Inc | Incorrect scatter information in the manual. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.