BEUDAMED
    78 results · 12ms · Sources: EU EUDAMED, US FDA

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    iba COMPASS SW Version 3.0, Catalog Number CS10-100 (medical linear accelerator) radiological

    FDA Enforcement
    Class II ·Terminated·Iba Dosimetry Gmbh·December 18, 2013

    Maquet Getinge- BEQ-TOP 54500 BSW-McLANE 3/8 Quadrox iD Material:709000496R01

    FDA Recall
    Terminated ·Maquet Cardiovascular, LLC·Product code DWF·April 18, 2019

    Maquet Getinge- BEQ-TOP 54500 BSW-McLANE 3/8 Quadrox iD Material:709000496R01

    FDA Enforcement
    Class II ·Terminated·Maquet Cardiovascular, LLC·June 5, 2019

    Carestream DRX Evolution System, X-Ray System --- The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.

    FDA Recall
    Terminated ·Carestream Health Inc.·Product code KPR·June 3, 2013

    Skytron Infinity Series surgical light, 4 bulbs in 1 - 22' diameter lighthead, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF54, IF54EL, IF54LH and IF54S.

    FDA Recall
    Terminated ·Skytron, Div. The KMW Group, Inc·Product code FTD·January 8, 2007

    Skytron Infinity series (also called Astro series) minor surgery light, 3 bulbs in 1 - 19' diameter lighthead, Manufactured by Dai-ichi Shomei Co., Ltd., Japan; Models IN19, IN19EL, IN19LH and IN19S.

    FDA Recall
    Terminated ·Skytron, Div. The KMW Group, Inc·Product code FTD·January 8, 2007

    Ergon III Series Skyboom Monitor Bracket. Part # 3FCM1 Flatscreen Bracket, single monitor mount, 27inch max. screen size

    FDA Recall
    Terminated ·Skytron, Div. The KMW Group, Inc·Product code FQO·March 28, 2016

    Skytron Infinity Series surgical light with triple lightheads, 4 bulbs in each of 3 - 22' diameter lightheads, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF545454 and IF545454EL.

    FDA Recall
    Terminated ·Skytron, Div. The KMW Group, Inc·Product code FTD·January 8, 2007

    Ergon 2 Articulating Equipment Boom Monitor Brackets mounting point for display interfaces utilized in clinical applications for viewing purposes and to provide an articulating point of movement on the ceiling mounted radial arm suspension system of the Ergon 2 equipment pendant / booms

    FDA Recall
    Terminated ·Skytron, Div. The KMW Group, Inc·Product code FQO·December 2, 2015

    Skytron Integrity 270 Steam Sterilizer and Skytron Integrity 270VP Steam Product Usage: The SKYTRON Integrity 270 Steam Sterilizer for use in health care facilities. The Integrity Sterilizer incorporates high-pressure steam to sterilize nonporous or porous items and materials used in the health care industry

    FDA Recall
    Terminated ·Skytron, Div. The KMW Group, Inc·Product code FLE·April 18, 2019

    Skytron General Purpose Surgical Table; Model 6600, Dist. by Skytron, Grand Rapids, MI.

    FDA Recall
    Terminated ·Skytron, Div. The KMW Group, Inc·Product code FQO·August 4, 2005

    Skytron Infinity Series surgical light with dual lightheads, 8 bulbs in 1 - 30' diameter lighthead and 5 bulbs in 1 - 22' diameter lighthead, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IN3022EL and IF3022EL. (note only the 22'' lighthead is affected).

    FDA Recall
    Terminated ·Skytron, Div. The KMW Group, Inc·Product code FTD·January 8, 2007

    Skytron Infinity Series surgical light, 5 bulbs in 1 - 22' diameter lighthead, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF22, IF22B, IF22LH, IF22LHH-B, IF22M-S, IN22, IN22EL, IN22LH and IF22(EL).

    FDA Recall
    Terminated ·Skytron, Div. The KMW Group, Inc·Product code FTD·January 8, 2007

    Skytron Infinity Series surgical light with dual lightheads, 5 bulbs in 1 - 22' lighthead and 8 bulbs in 1 - 30' diameter lighthead, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Model IF3022B. (note only the 22'' lighthead is affected.)

    FDA Recall
    Terminated ·Skytron, Div. The KMW Group, Inc·Product code FTD·January 8, 2007

    Skytron Infinity Series surgical light with dual lightheads, 5 bulbs in each of 2 - 22' diameter lightheads, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF2222, IF2222-B, IF2222B/PT, IF2222EL and IN2222EL.

    FDA Recall
    Terminated ·Skytron, Div. The KMW Group, Inc·Product code FTD·January 8, 2007

    Skytron Infinity Series surgical light with dual lightheads, 4 bulbs in each of 2 - 22' diameter lightheads, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF5454 and IF5454EL.

    FDA Recall
    Terminated ·Skytron, Div. The KMW Group, Inc·Product code FTD·January 8, 2007

    Skytron Infinity Series surgical light with triple lightheads, 8 bulbs in 1 - 30' diameter lighthead and 5 bulbs in each of 2 - 22' diameter lightheads, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Model IN302222EL, IF302222-B, IN30AR2222EL and IN30TV2222EL. (note only the 22'' lightheads are affected).

    FDA Recall
    Terminated ·Skytron, Div. The KMW Group, Inc·Product code FTD·January 8, 2007

    Skytron General Purpose Surgical Table, battery model; Model 6600B, Dist. by Skytron, Grand Rapids, MI.

    FDA Recall
    Terminated ·Skytron, Div. The KMW Group, Inc·Product code FQO·August 4, 2005

    Skytron Infinity Series (also called Astro series) minor surgery light with dual lightheads, 3 bulbs in each of 2 - 19' diameter lightheads, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IN1919 and IN1919EL and IN1919EL/PT.

    FDA Recall
    Terminated ·Skytron, Div. The KMW Group, Inc·Product code FTD·January 8, 2007

    VGDF-SKY (R4-010-06) VGA TO FIBER CONVERTER-Single Format Faceplate, a component of the SkyVision Linx 300 Integration Control System Model: VGDF-SKY (version 2). For communication and visual image management in the operating room suite.

    FDA Recall
    Terminated ·Skytron, Div. The KMW Group, Inc·Product code LMD·September 11, 2020