BEUDAMED
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    The Stryker Visum¿ LED Surgical Lighting system is intended to illuminate the operative site during surgical procedures with high intensity light. Affected part numbers are 0682001432 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 9P/FP), 0682001286 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 5P/FP), 0682001298 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 5P), 0682001299 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 5P/5P), 0682001300 (EDS LIGHT SUSPENSION, CENTRAL AXIS, FP/5P/5P), 0682001433 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 9P), 0682001434 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 9P/5P), 0682001435 (EDS LIGHT SUSPENSION, CENTRAL AXIS, FP/9P/5P) Product Usage: The Stryker Visum LED Surgical Lighting system is intended to illuminate the operative site during surgical procedures with high intensity light

    FDA Enforcement
    Class II ·Terminated·Stryker Communications·April 5, 2017

    The Stryker Visum LED Surgical Lighting system is intended to illuminate the operative site during surgical procedures with high intensity light. Affected part numbers are 0682001432 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 9P/FP), 0682001286 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 5P/FP), 0682001298 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 5P), 0682001299 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 5P/5P), 0682001300 (EDS LIGHT SUSPENSION, CENTRAL AXIS, FP/5P/5P), 0682001433 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 9P), 0682001434 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 9P/5P), 0682001435 (EDS LIGHT SUSPENSION, CENTRAL AXIS, FP/9P/5P) Product Usage: The Stryker Visum LED Surgical Lighting system is intended to illuminate the operative site during surgical procedures with high intensity light

    FDA Recall
    Terminated ·Stryker Communications·Product code FSY·February 28, 2017

    NOMAD Pro2 Packaged X-Ray System, Part Number 08500021; NOMAD Pro2 Packaged X-Ray System Black, Part Number 08500022; NOMAD Pro2 Vet Packaged X-Ray System, Part Number 08500023; NOMAD Pro2 Vet Packaged X-Ray System Black, Part Number 08500024; NOMAD Pro2 Packaged X-Ray System, GBL, Part Number 08500025 and Part Number 08500026; NOMAD Pro2 Packaged X-Ray System, GLB, Vet, Part Number 08500027 and Part Number 08500028; NOMAD Pro2 Package X-Ray System, GLB, Black, Part Number 08500029

    FDA Enforcement
    Class II ·Terminated·Aribex Inc·September 14, 2016

    Gamma camera systems: AXIS SPECT Systems & IRIX SPECT Systems, Model #: AXIS- 882130, IRIX- 882140. Philips Healthcare. Used to do nuclear medicine diagnostic imaging of various body organs.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code KPS·November 18, 2011

    Convenience Kits from Centurion that contain an In-Vision- Plus Needleless IV Connector, Model: code RYM5001 InVision-Plus¿ Needless IV Connectors are used for single patient use in IV and blood administration sets without the need for needles, thus eliminating the potential for needle-stick injuries during use.

    FDA Enforcement
    Class II ·Terminated·Centurion Medical Products Corporation·March 2, 2016

    Portex Dual-Axis Swivel Adapter Catalog Number: 525151

    FDA Recall
    Terminated ·Smiths Medical ASD, Inc.·September 9, 2004

    AXIS (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015

    IPELA FHD PTZ TILE KITS with Axis cameras used in combination with Natus Neuroworks/Sleepworks software

    FDA Enforcement
    Class II ·Terminated·Natus Neurology DBA Excel Tech., Ltd. (XLTEK)·March 2, 2022

    Axis-Shield DIASTAT Anti-CCP test kit, (code FCCP200)

    FDA Recall
    Terminated ·Product code NHX·November 11, 2005

    Fiberoptic Bronchoscope Dual-Axis Swivel Adapter Catalog Number: 625191

    FDA Recall
    Terminated ·Smiths Medical ASD, Inc.·September 9, 2004

    Coonrad/Morrey New Ulnar Revision Kit for Use with Non-Interchangeable Regular Humerals STERILE Rx, Tivanium QTY/PKG:1 Product Usage: The ulnar and humeral components are connected by placing the hollow, outer axis pin across the two components and securing It with the solid Internal axis pin. The Inner and outer pin connection Is articulation point of the placement elbow.

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·December 26, 2012

    Portex PEEP-KEEP Dual-Axis Swivel Adapter Catalog Number: 525351

    FDA Recall
    Terminated ·Smiths Medical ASD, Inc.·September 9, 2004

    Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT; 100 test format, 1000 test format, and 200 test format; and Private Label: (Distributed by BECKMAN COULTER, for professional use only, on the BECKMAN COULTER AU platforms (AU400, AU480, AU680 and AU5800)) Product Usage: For in-vitro quantitative determination of total homocysteine in human plasma or serum.

    FDA Recall
    Terminated ·Product code LPS·March 20, 2015

    Axis Gamma Camera, Scintillation (gamma) camera, Philips Medical System, Cleveland, OH 44143

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code KPS·November 21, 2007

    Philips Odyssey FX Workstations, used with Axis, Irix, or Meridian Gamma Camera Systems.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code LLZ·September 15, 2003

    Philips Odyssey VP Workstations, used with Axis, Irix, or Meridian Gamma Camera Systems.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code LLZ·September 15, 2003

    Philips Odyssey LX Workstations, used with Axis, Irix, or Meridian Gamma Camera Systems.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code LLZ·September 15, 2003

    Acuvue Advance for Astigmatism Diagnostic Product. Expected Primary Package Label: Lot B0077KM 3.75D 1.7cyl. 180 Axis Exp. 2014/07. Actual Primary Package Label: Lot B007NV5 7.50D 1.75cyl. 20 Axis Exp. 2014/12. Product was provided to Eye Care professionals to use as diagnostic replenishment. Product used by Eye Care professionals in the fitting process.

    FDA Recall
    Terminated ·Vistakon·Product code LPL·April 20, 2009

    COONMAD/MORREY TOTAL ELBOW ELBOW COMPONENT REPLACEMENT SET BUSHINGS & PINS FOR USE W/SIZE REGULAR ELBOW ELBOW COMP REPLACEMENT-REG SET STERILE PROD CLASS: 4100 OPERATION:9000 QTY/PKG:1 Product Usage: The ulnar and humeral components are connected by placing the hollow, outer axis pin across the two components and securing It with the solid Internal axis pin. The Inner and outer pin connection Is articulation point of the placement elbow.

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·December 26, 2012

    Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT; 100 test format, 1000 test format, and 200 test format; and Private Label: (Distributed by BECKMAN COULTER, for professional use only, on the BECKMAN COULTER AU platforms (AU400, AU480, AU680 and AU5800)) Product Usage: For in-vitro quantitative determination of total homocysteine in human plasma or serum.

    FDA Enforcement
    Class II ·Terminated·Axis-Shield Diagnostics, Ltd.·July 8, 2015