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    Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A The software is applicable to the following CT systems: Aquilion ONE TSX-301A/2D X-ray CT system with a 320-row 0.5 mm detector is provided with a 7.5-MHU large-capacity X-ray tube unit, and permits scanning over large areas at the high-speed of 0.35 s per rotation. The system features are; 160-mm-wide area detector, station, gantry and patient couch operation controls, image reconstruction, high-speed volume scan, high-quality images, selectable image slice thickness, dual-monitor system, improved image diagnosis functions, high-speed volume data workflow, exposure reduction, ECG-gated scan and reconstruction, and SUREFluoro.

    FDA Enforcement
    Class II ·Terminated·Toshiba American Medical Systems Inc·December 3, 2014

    Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A The software is applicable to the following CT systems: Aquilion ONE TSX-301C X-ray CT system with a 320-row 0.5 mm detector is provided with a 7.5-MHU large-capacity X-ray tube unit, and permits scanning over large areas at the high-speed of 0.35 s per rotation. The system features are; 160-mm-wide area detector, station, gantry and patient couch operation controls, image reconstruction, high-speed volume scan, high-quality images, selectable image slice thickness, dual-monitor system, improved image diagnosis functions, high-speed volume data workflow, exposure reduction, ECG-gated scan and reconstruction, and SUREFluoro. The CT cardiac function analysis software is used to analyze cardiac function using data obtained by performing cardiac MPR processing for ECG-gated scan data according to the cardiac axis. Aquilion ONE is a dynamic volume CT system that supports whole-body scanning. This 320-detector row system generates 640 slices per rotation using the coneXact reconstruction algorithm. In addition, the high-speed rotation mechanism and the fast reconstruction unit of the system allow the rapid image acquisition to further improve throughput in CT examinations.

    FDA Enforcement
    Class II ·Terminated·Toshiba American Medical Systems Inc·December 3, 2014

    Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A The software is applicable to the following CT systems: Aquilion ONE TSX-301A/2D X-ray CT system with a 320-row 0.5 mm detector is provided with a 7.5-MHU large-capacity X-ray tube unit, and permits scanning over large areas at the high-speed of 0.35 s per rotation. The system features are; 160-mm-wide area detector, station, gantry and patient couch operation controls, image reconstruction, high-speed volume scan, high-quality images, selectable image slice thickness, dual-monitor system, improved image diagnosis functions, high-speed volume data workflow, exposure reduction, ECG-gated scan and reconstruction, and SUREFluoro.

    FDA Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code JAK·November 5, 2014

    MicroStic Plus w/SS Wire 5F and MicroStic Plus w/NiTi Wire & Echo Needle 4F. A sheath used to facilitate placing a catheter through the skin into a vein or artery.

    FDA Enforcement
    Class II ·Terminated·Argon Medical Devices, Inc·October 12, 2016

    MicroStic Plus w/SS Wire 5F and MicroStic Plus w/NiTi Wire & Echo Needle 4F. A sheath used to facilitate placing a catheter through the skin into a vein or artery.

    FDA Recall
    Terminated ·Argon Medical Devices, Inc·Product code DYB·September 8, 2016

    Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A The software is applicable to the following CT systems: Aquilion ONE TSX-301C X-ray CT system with a 320-row 0.5 mm detector is provided with a 7.5-MHU large-capacity X-ray tube unit, and permits scanning over large areas at the high-speed of 0.35 s per rotation. The system features are; 160-mm-wide area detector, station, gantry and patient couch operation controls, image reconstruction, high-speed volume scan, high-quality images, selectable image slice thickness, dual-monitor system, improved image diagnosis functions, high-speed volume data workflow, exposure reduction, ECG-gated scan and reconstruction, and SUREFluoro. The CT cardiac function analysis software is used to analyze cardiac function using data obtained by performing cardiac MPR processing for ECG-gated scan data according to the cardiac axis. Aquilion ONE is a dynamic volume CT system that supports whole-body scanning. This 320-detector row system generates 640 slices per rotation using the coneXact reconstruction algorithm. In addition, the high-speed rotation mechanism and the fast reconstruction unit of the system allow the rapid image acquisition to further improve throughput in CT examinations.

    FDA Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code JAK·November 5, 2014

    Hudson RCI Sheridan/CF: a) 3.0 mm, REF 5-10106, REF 5-10206 b) 3.5 mm, REF 5-10107 c) 4.0 mm, REF 5-10108, REF 5-10208 d) 4.5 mm, REF 5-10109 e) 5.0 mm, REF 5-10110, REF 5-10210 f) 5.5 mm, REF 5-10111 g) 6.0 mm, REF 5-10112, REF 5-10212 h) 6.5 mm, REF 5-10113, REF 5-10213 I) 7.0 mm, REF 5-10114, REF 5-10214 j) 7.5 mm, REF V5-10115, REF 5-10115, REF 5-10215 k) 8.0 mm, REF 5-10116, REF 5-10216, REF V5-10116 l) 8.5 mm, REF 5-10117, REF 5-10217 m) 9.0 mm, REF 5-10118, REF5-10218 n) 9.5 mm, REF 5-10119 o) 10.0 mm, REF 5-10120, REF 5-10220 Product Usage: Tracheal tube/airway management

    FDA Recall
    Terminated ·Teleflex Medical·Product code BTR·July 30, 2019

    Hudson RCI Sheridan/CF: a) 3.0 mm, REF 5-10106, REF 5-10206 b) 3.5 mm, REF 5-10107 c) 4.0 mm, REF 5-10108, REF 5-10208 d) 4.5 mm, REF 5-10109 e) 5.0 mm, REF 5-10110, REF 5-10210 f) 5.5 mm, REF 5-10111 g) 6.0 mm, REF 5-10112, REF 5-10212 h) 6.5 mm, REF 5-10113, REF 5-10213 I) 7.0 mm, REF 5-10114, REF 5-10214 j) 7.5 mm, REF V5-10115, REF 5-10115, REF 5-10215 k) 8.0 mm, REF 5-10116, REF 5-10216, REF V5-10116 l) 8.5 mm, REF 5-10117, REF 5-10217 m) 9.0 mm, REF 5-10118, REF5-10218 n) 9.5 mm, REF 5-10119 o) 10.0 mm, REF 5-10120, REF 5-10220 Product Usage: Tracheal tube/airway management

    FDA Enforcement
    Class I ·Terminated·Teleflex Medical·September 18, 2019

    Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN DESCRIPTION M001271540 FLEXIMA BILIARY FIRM 8F/35CM M001271550 FLEXIMA BILIARY FIRM 10F/35CM M001271560 FLEXIMA BILIARY REG 8F/35CM M001271570 FLEXIMA BILIARY REG 10F/35CM M001271580 FLEXIMA BILIARY REG 12F/35CM M001271590 FLEXIMA BILIARY REG 14F/35CM M001271600 FLEXIMA BILIARY SOFT 10F/35CM M001271610 FLEXIMA BILIARY SOFT 12F/35CM M001271620 FLEXIMA BILIARY SOFT 14F/35CM M001281560 FLEXIMA BILIARY 8/35 TT M001281570 FLEXIMA BILIARY 10/35 TT M001281580 FLEXIMA BILIARY 12/35 TT M001281590 FLEXIMA BILIARY 14/35 TT M001271630 FLEXIMA BIL 8F/35CM FIRM KIT M001271640 FLEXIMA BIL 10F/35CM FIRM KIT M001271650 FLEXIMA BIL 8F/35CM REG KIT M001271660 FLEXIMA BIL 10F/35CM REG KIT Single Use Only, Sterilized with Ethylene Oxide Gas, Boston Scintific Corporation, One Boscton Scintific Place, Natick, MA 01760-1537, Made in USA 780 Brookside Drive, Spencer, IN 47460 1080. Designed for percutaneous drainage of abscess fluid, the Biliary system and the urinary tract.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code FFA·March 18, 2009

    - Average Medium Blade 9mm x 25mm x 0.38mm Ref. 2296-3-111 Lot 122590, 122447 - Cannulated Drill Bit, Quick Coupling, For 3.5 & 4mm Cannulated Screws, 1.35mm Cannulation 2.7mm x 160mm Ref. 310.67 Lot 122289 - Hall MicroChoice, Oscillating Blade, Fine, Flat, Stainless Steel 5.5mm x 12.0mm x 0.4mm Ref. 5023-160 Lot 123353 - Hall MicroChoice, Oscillating Saw Blade, Fine, Flat, Stainless Steel 5.5mm x 18.5mm x 0.4mm Ref. 5023-162 Lot 123353 - Hall MicroChoice, Sagittal Saw Blade, Fine 4.5mm x 25.5mm x 0.4mm Ref. 5023-139 Lot 122454 - Hall MicroChoice, Sagittal Saw Blade, Stainless Steel 9.5mm x 25.5mm x 0.4mm Ref. 5023-138 Lot 122454, 123353 - Large Sagittal Saw Blade 25mm x 89.5mm x 0.89mm Ref. 2108-102 Lot 122490 - Micro Choice Oscillating Saw Blade 5.5mm x 18.5mm x 0.40mm Ref. KM-3000 Lot 122440 - Micro Oscillating and Sagittal Saw Blade 9.0mm x 25mm x 0.51mm Ref. 2296-33-521 Lot 122609, 122429 - Oscillating and Sagittal Saw Blade 9.0mm x 31mm x 0.51mm Ref. 2296-33-225 Lot 122347 - Oscillating Sagittal Blade 9mm x 31mm x .38mm Ref. 2296-3-525 Lot 123263 - Oscillating Saw Blade 9.0mm x 25.0mm x .38mm Ref. SP-511 Lot 122631 - Oscillating Saw Blade 9mm x 25mm x .38mm Ref. 2296-3-511 Lot 122447 - Reciprocating Saw Blade, Double Sided Fixed Point Travel: 3.56mm 70mm x 12.5mm x 0.64mm Ref. 227-96-275 Lot 122490 - Round Fast Cutting Stainless Steel Bur, 8 Flute 4.8mm Ref. 1608-6-139 Lot 122447 - Sagittal Saw Blade 4.5mm x 25.4mm Ref. KM-3102 Lot 122465 - Small Oscillating Blade 9.0mm x 31.0mm x .4mm Ref. 2296-3-125 Lot 122447 - Small Oscillating Saw Blade 5.5mm x 11.5mm x 0.38mm Ref. 2296-3-410 Lot 122429 - Small Oscillating Saw Blade 5.5mm x 18.0mm x 0.4mm Ref. 2296-3-212 Lot 122511 - Small Oscillating Saw Blade 5.5mm x 18mm x 0.38mm Ref. 2296-3-412 Lot 122447 - Small Oscillating Saw Blade 7mm x 18.5mm x 0.38mm Ref. 2296-3-114 Lot 122429, 122511 - Small Oscillating Saw Blade 9.0mm x 31mm x 0.4mm Ref. 2296-3-225 Lot 122590, 122447 - Small Sagittal Saw Blade, Fine Tooth 9.5mm x 25.5mm x 0.4mm Ref. ZS-338 Lot 122647 - System 4 & System 2000 Sagittal Saw Blade 12.5mm x 81.5mm x 1.19mm Ref. 2108-152 Lot 122490 - System 4, System 2000 & EHD Sagittal Saw Blade, Dual Cut 1.27mm x 11mm x 90mm Ref. 4111-127-090 Lot 123263 - System 4, System 2000 & EHD Sagittal Saw Blade, Dual Cut 18mm x 75mm x 0.89mm Ref. 4118-089-075 Lot 123263 - System 4, System 2000 & EHD Sagittal Saw Blade, Dual Cut 25mm x 90mm x 1.27mm Ref. 4125-127-090 Lot 122347 - System 4, System 2000 & EHD Sagittal Saw Blade, Dual-Cut 18mm x 90mm x 1.35mm Ref. 4118-135-090 Lot 122347 Surgical instrument motors and accessories/attachments

    FDA Recall
    Terminated ·Surgical Instrument Service And Savings, Inc.·Product code GFA·May 3, 2013

    Solara Replacement Turbine, Autochuck End Cap, for dental handpiece, part number 064900.

    FDA Recall
    Terminated ·Stardental Division·Product code EFA·December 1, 2006

    Terumo Sarns Sternal Saw II System Power Unit, 115 V, Terumo Cardiovascular Systems Corp., Ann Arbor, MI; Catalog # 15670. Indicated for use in medial sternotomies. The Sarns Sternal Saw II system consists of a disposable blade, saw, flexible drive shaft, motor and foot control.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code GFA·February 14, 2008

    Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN# DESCRIPTION 435428-01 M001273030 FLEXIMA VSCL REG 12FR/35CM M001273040 FLEXIMA VSCL REG 14FR/35CM M001273090 FLEXIMA VSDC REG LOOP 12/35KIT M001273100 FLEXIMA VSDC REG LOOP 14/35KIT M001273150 FLEXIMA VSCL FIRM 12FR/35CM M001273160 FLEXIMA VSCL FIRM 14FR/35CM M001273210 FLEXIMA VSDC FIRM LOOP 12/35 M001273220 FLEXIMA VSDC FIRM LOOP 14/35 Single Use Only, Sterilized with Ethylene Oxide Gas, Boston Scintific Corporation, One Boscton Scintific Place, Natick, MA 01760-1537, Made in USA 780 Brookside Drive, Spencer, IN 47460 1080. Designed for percutaneous drainage of abscess fluid, the Biliary system and the urinary tract.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code FFA·March 18, 2009

    Formula Shaver Handpiece (with buttons); Formula 180 Shaver Handpiece (with button) Rx only, Made USA.: Stryker Endoscopy 5900 Optical Court San Jose, CA 95138 Components within the Crossfire System that provided abrasion, resection, debridement and removal of bone and soft tissue through the Formula Shaver and blade, and the ablation and coagulation of soft tissue, as well as hemostasis of blood vessels through its SERFAS Energy electrosurgical probe.

    FDA Recall
    Terminated ·Stryker Endoscopy·Product code GFA·May 21, 2012

    Zimmer Oscillating Flat - TS ST Hub; 75mm x 19mm x 1.00/1.27mm; Synvasive Part No. 11-4770: Part No. 19075127YT1; Lot No. 45104 and 43054 Description: STRYK_76542K_19X75X1.27T General and Plastic Surgery: The oscillating surgical saw blade is intended for use with powered equipment to resect bone and/or cartilage in orthopedic procedures

    FDA Recall
    Terminated ·Synvasive Technology Inc·Product code GFA·December 8, 2015

    Terumo Sarns Sternal Saw II System Power Unit, 220/240 V, Terumo Cardiovascular Systems Corp., Ann Arbor, MI; Catalog # 7084. Note: This product was not sold in the U.S. Indicated for use in medial sternotomies. The Sarns Sternal Saw II system consists of a disposable blade, saw, flexible drive shaft, motor and foot control.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code GFA·February 14, 2008

    Exact Calcar Planer Rasp Style Blade, 42mm, Biomet Orthopedics, Inc, Warsaw, IN; REF 31-473796. Surgical blades used to remove excess bone proximal to the broach face to all instrument trial to seat properly.

    FDA Recall
    Terminated ·Biomet, Inc.·Product code GFA·July 18, 2008

    Exact Calcar Planer Rasp Style Blade, 50mm, Biomet Orthopedics, Inc, Warsaw, IN; REF 31-473798. Surgical blades used to remove excess bone proximal to the broach face to all instrument trial to seat properly.

    FDA Recall
    Terminated ·Biomet, Inc.·Product code GFA·July 18, 2008

    Exact Calcar Planer Rasp Style Blade, 46mm, Biomet Orthopedics, Inc, Warsaw, IN; REF 31-473797. Surgical blades used to remove excess bone proximal to the broach face to all instrument trial to seat properly.

    FDA Recall
    Terminated ·Biomet, Inc.·Product code GFA·July 18, 2008

    Product is distributed by Zimmer (Warsaw, Indiana)/Synvasive Technology, Inc. (El Dorado Hills, CA) & manufactured under Synvasive Technology, Inc. El Dorado Hills, CA Reciprocating saw blade: A sterile surgical saw blade used to resect damaged cartilage and/or bond in an orthopaedic reconstructive procedure such as a total knee replacement.

    FDA Recall
    Terminated ·Synvasive Technology Inc·Product code GFA·April 2, 2013