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Beyes

Beyes Dental Canada Inc · Model DS1108 · UDI-DI 00990010302457

MUH Prescription
1
510(k) clearances
65
Adverse events
9
Recalls
90
Facilities

Description

Bite Block Size #1, Refill 12/PK

Recalls

DateFirmReason
2019-04-29KaVo Dental Technologies LLCThe sensor's look up calibration files were incorrectly programmed during manufacturing, which can result in the reduction of image quality.
2015-08-05Villa Radiology Systems LLCIt 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).
2015-01-08Carestream Health, Inc.Units device head descended unexpectedly
2015-01-08Carestream Health, Inc.Units device head descended unexpectedly
2014-09-04Midmark Corp dba Progeny IncFailure 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.
2013-09-20Midmark Corp dba Progeny IncAn 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
2009-03-06Gendex Dental SystemsThere 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
2009-01-08Imaging Sciences International, LLCfaulty calibration
2008-03-19Imaging Sciences Intl IncIncorrect scatter information in the manual.

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Data 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.