BEUDAMED
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    Magnetic Resonance Imaging Diagnostic Device accessory - Product Usage: The chest pneumograph (also referred to as the pneumatic bellows, respiration bellows, or respiration sensor) monitors bellows-derived respiration by detecting abdominal or chest wall motion. The chest pneumograph is an accessory to a MRI patient monitoring system or MRI gating solution. The Chest Pneumograph is indicated for use by healthcare professionals with the Wireless Sp02 (wSp02) Module or Toshiba KSB gating unit when bellows-derived respiration sensing is needed during MRI scans for gating.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·June 10, 2020

    Cardiovascular Monitoring Device accessory - Product Usage: The chest pneumograph (also referred to as the pneumatic bellows, respiration bellows, or respiration sensor) monitors bellows-derived respiration by detecting abdominal or chest wall motion. The chest pneumograph is an accessory to a MRI patient monitoring system or MRI gating solution. The Chest Pneumograph is indicated for use by healthcare professionals with the Wireless Sp02 (wSp02) Module or Toshiba KSB gating unit when bellows-derived respiration sensing is needed during MRI scans for gating.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·June 10, 2020

    Cardiovascular Monitoring Device accessory - Product Usage: The chest pneumograph (also referred to as the pneumatic bellows, respiration bellows, or respiration sensor) monitors bellows-derived respiration by detecting abdominal or chest wall motion. The chest pneumograph is an accessory to a MRI patient monitoring system or MRI gating solution. The Chest Pneumograph is indicated for use by healthcare professionals with the Wireless Sp02 (wSp02) Module or Toshiba KSB gating unit when bellows-derived respiration sensing is needed during MRI scans for gating.

    FDA Recall
    Terminated ·Philips North America, LLC·Product code MWI·April 13, 2020

    Magnetic Resonance Imaging Diagnostic Device accessory - Product Usage: The chest pneumograph (also referred to as the pneumatic bellows, respiration bellows, or respiration sensor) monitors bellows-derived respiration by detecting abdominal or chest wall motion. The chest pneumograph is an accessory to a MRI patient monitoring system or MRI gating solution. The Chest Pneumograph is indicated for use by healthcare professionals with the Wireless Sp02 (wSp02) Module or Toshiba KSB gating unit when bellows-derived respiration sensing is needed during MRI scans for gating.

    FDA Recall
    Terminated ·Philips North America, LLC·Product code MWI·April 13, 2020

    Interlink Y-Type Blood/Solution Set with Standard Bore 4-way Stopcock Extension Set, catalog #3C0116; Standard Blood Filter (170 to 260 micron), Drip Chamber Pump, Injection Site, Male Luer Lock Adapter, 97'' long, 10 drops per mL plus Standard Bore 4-way Stopcock Extension Set, 35'' long, 5.2 mL volume, Male Luer Lock Adapter; Baxter Healthcare Corporation, Deerfield, IL 60015

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt·Product code KSB·December 18, 2002

    Fenwal Y-Type Blood Component Recipient Set with Standard Blood Filter, 10 drops/mL, 65'', 170 to 260 Micron Filter, catalog 4C2196; Baxter Healthcare Corporation, Deerfield, IL 60015 USA

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt·Product code KSB·July 16, 2003

    Y-Type Blood/Solution Set, catalog #1C8117; Standard Blood Filter (170 to 260 micron), Drip Chamber Pump, Injection Site, Male Luer Lock Adapter, 88'' long, 10 drops per mL; Baxter Healthcare Corporation, Deerfield, IL 60015

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt·Product code KSB·December 18, 2002

    Baxter Y-Type Blood/Solution Set with Pressure Pump, 10 drops/mL, 99'', 170 to 260 Micron Filter,Large Standard Blood Filter, 2 Injection Sites, Male Luer Lock Adapter, catalog 2C6723; Baxter Healthcare Corporation, Deerfield, IL 60015 USA

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt·Product code KSB·July 16, 2003

    Clearlink System Y-Type Blood/Solution Set, 10 drops/mL, 112'', Standard Blood Filter, 170 to 260 Micron Filter, Luer Activated Valve, Male Luer Lock Adapter, catalog 2C8750; Baxter Healthcare Corporation, Deerfield, IL 60015 USA

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt·Product code KSB·July 16, 2003

    Fenwal Y-Type Blood/Solution Set with Large Standard Blood Filter and Pressure Pump, 15 drops/mL, 99'', 170 to 260 Micro Filter, Large Standard Blood Filter, 2 Injection Sites, Male Luer Lock Adapter, catalog 4C6723; Baxter Healthcare Corporation, Deerfield, IL 60015 USA

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt·Product code KSB·July 16, 2003

    Y-Type Blood/Solution Set, catalog #1C8029; Standard Blood Filter (170 to 260 micron), Drip Chamber Pump, Injection Site, Male Luer Lock Adapter, 111'' long, 10 drops per mL; Baxter Healthcare Corporation, Deerfield, IL 60015

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt·Product code KSB·December 18, 2002

    Y-Type Blood/Solution Set, catalog #1C8372; Standard Blood Filter (170 to 260 micron), Drip Chamber Pump, 2 Injection Sites, Male Luer Lock Adapter, 111'' long, 10 drops per mL; Baxter Healthcare Corporation, Deerfield, IL 60015

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt·Product code KSB·December 18, 2002

    Y-Type Blood/Solution Set with Pressure Pump, catalog #1C8658; Standard Blood Filter (170 to 260 micron), Drip Chamber Pump, Injection Site, Male Luer Lock Adapter, 109'' long, 10 drops per mL; Baxter Healthcare Corporation, Deerfield, IL 60015

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt·Product code KSB·December 18, 2002

    Y-Type Blood/Solution Set, catalog #1C8459; Standard Blood Filter (170 to 260 micron), Drip Chamber Pump, 3 Injection Sites, Male Luer Lock Adapter, 111'' long, 10 drops per mL; Baxter Healthcare Corporation, Deerfield, IL 60015

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt·Product code KSB·December 18, 2002

    Fenwal Blood Component Recipient Set with Standard Blood Filter, 10 drops/mL, 55'', 170 to 260 Micron Filter, catalog 4C2100; Baxter Healthcare Corporation, Deerfield, IL 60015 USA

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt·Product code KSB·July 16, 2003

    Multiples Anspach Micro Curved Attachments (MCA) and Curved Burr Support S leves (Cutters and Attachments) MCA - MICRO CURVED ATTACHMENT, MCA5-05SD - 0.5MM DIAMOND BALL, 5.6CM, MCA5-06SD - 0.6MM DIAMOND BALL, 5.6CM, MCA5-07SD - 0.7MM DIAMOND BALL, 5.6CM, MCA5-08SD - 0.8MM DIAMOND BALL, 5.6CM, MCA5-15SB - 1.5MM FLUTED BALL, 5.6CM, MCA5-15SD - 1.5MM DIAMOND BALL, 5.6CM, MCA5-1SB - lMM FLUTED BALL, 5.6CM, MCA5-1SD - lMM DIAMOND BALL, 5.6CM, MCA5-2SB - 2MM FLUTED BALL, 5.6CM, MCA5-2SD - 2MM DIAMOND BALL, 5.6CM, MCA7-05SD - 0.5MM DIAMOND BALL, 7.3CM, MCA7-06SD - 0.6MM DIAMOND BALL, 7 .3CM, MCA7-07SD - 0.7MM DIAMOND BALL, 7.3CM, MCA7-08SD - 0.8MM DIAMOND BALL, 7.3CM, MCA7-15SB - 1.5MM FLUTED BALL, 7.3CM, MCA7-15SD  1.5MM DIAMOND BALL, 7.3CM, MCA7-1SB - lMM FLUTED BALL, 7.3CM, MCA7-1SD - 1 MM DIAMOND BALL, 7 .3CM, MCA7-2SB - 2MM FLUTED BALL, 7.3CM and MCA7-2SD - 2MM DIAMOND BALL, 7.3CM. The MCA attachment is a reusable device used with dissection tools. Dissection tools are single use, disposable cutter designed for cutting and shaping delicate bone, primary in otology procedures for delicate bone cutting.

    FDA Enforcement
    Class II ·Terminated·The Anspach Effort, Inc.·January 15, 2014

    Multiples Anspach Micro Curved Attachments (MCA) and Curved Burr Support S leves (Cutters and Attachments) MCA - MICRO CURVED ATTACHMENT, MCA5-05SD - 0.5MM DIAMOND BALL, 5.6CM, MCA5-06SD - 0.6MM DIAMOND BALL, 5.6CM, MCA5-07SD - 0.7MM DIAMOND BALL, 5.6CM, MCA5-08SD - 0.8MM DIAMOND BALL, 5.6CM, MCA5-15SB - 1.5MM FLUTED BALL, 5.6CM, MCA5-15SD - 1.5MM DIAMOND BALL, 5.6CM, MCA5-1SB - lMM FLUTED BALL, 5.6CM, MCA5-1SD - lMM DIAMOND BALL, 5.6CM, MCA5-2SB - 2MM FLUTED BALL, 5.6CM, MCA5-2SD - 2MM DIAMOND BALL, 5.6CM, MCA7-05SD - 0.5MM DIAMOND BALL, 7.3CM, MCA7-06SD - 0.6MM DIAMOND BALL, 7 .3CM, MCA7-07SD - 0.7MM DIAMOND BALL, 7.3CM, MCA7-08SD - 0.8MM DIAMOND BALL, 7.3CM, MCA7-15SB - 1.5MM FLUTED BALL, 7.3CM, MCA7-15SD 1.5MM DIAMOND BALL, 7.3CM, MCA7-1SB - lMM FLUTED BALL, 7.3CM, MCA7-1SD - 1 MM DIAMOND BALL, 7 .3CM, MCA7-2SB - 2MM FLUTED BALL, 7.3CM and MCA7-2SD - 2MM DIAMOND BALL, 7.3CM. The MCA attachment is a reusable device used with dissection tools. Dissection tools are single use, disposable cutter designed for cutting and shaping delicate bone, primary in otology procedures for delicate bone cutting.

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code HBE·October 26, 2012

    Anspach Carbide Cutting Burrs: 2MM Carbide Fluted Ball, Standard, 8 Flutes - part #QD8-2SB-C-8F, 4MM Carbide Fluted Ball, 10 Flutes - part # QD8-4B-C-10F 5MM Carbide Fluted Ball, 10 Flutes - part #QD8-5B-C-10F 7MM Carbide Fluted Ball, 14 Flutes - part #QD8-7B-C-14F Anspach cutting burrs are intended for cutting and shaping bone, including the spine and cranium

    FDA Enforcement
    Class II ·Terminated·The Anspach Effort, Inc.·January 22, 2014

    MCA7-1SB - 1MM Fluted Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.

    FDA Enforcement
    Class II ·Terminated·The Anspach Effort, Inc.·January 22, 2014

    MCA7-2SB - 2MM Fluted Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.

    FDA Enforcement
    Class II ·Terminated·The Anspach Effort, Inc.·January 22, 2014