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    ***REF IMRI-MOTOR***iMRI Handpiece. Use with iMRI System Only***Rx Only***Manufacturer: The Anspach Effort, Inc. Intended for cutting and shaping bone.

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code HBB·April 25, 2013

    Sterile Bone Cutting Burrs model IMRI-S-8NS-M labeled in part:***IMRI-S-8NS-M***QTY: 1***3 mm Fluted Matchstick, Extends 8.9 mm,***Less Aggressive. Use with IMRI-SHORT***Attachments.***Use by 2014 08***ANSPACH***Manufacturer***Made in USA***The Anspach Effort, Inc.***4500 Riverside Drive***Palm Beach Gardens, FL 33410, USA***Tel: (800) 327 6887 / + 1 561 627 1080***EC REP***Anspach Europe Ltd.***Aston Court, Kingsmead Business Park***Frederick Place***High Wycombe, HP 11 1LA***United Kingdom***Tel: +441494 616126***Rx Only***LOT C323023789***. Cutting and Shaping bone including bones of the spine and cranium.

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code HBC·May 9, 2011

    IMRIS ORT100 (Part Number 110470-000) and ORT200 (Part Number 112216-00), are tables used in both the Neuro II-SE and Neuro III-SV Magnetic Resonance Imaging Systems.

    FDA Recall
    Terminated ·Innovative Magnetic Resonance Imaging Systems Inc.·Product code LNH·October 19, 2012

    IMRIS Operating Room table (ORT200 and ORT300). Intended for use during diagnostic examinations or surgical procedures to support and position a patient.

    FDA Recall
    Terminated ·IMRIS Inc·Product code FQO·October 1, 2014

    Sterile Bone Cutting Burrs model M-6P labeled in part:***M-6P***QTY: 1***6 mm x 9 mm Fluted Pear.***Use with*** MEDIUM Attachments.***Use by 2015-12***ANSPACH***Manufacturer***Made in USA***The Anspach Effort, Inc.***4500 Riverside Drive***Palm Beach Gardens, FL 33410, USA***Tel: (800) 327 6887 / + 1 561 627 1080***EC REP***Anspach Europe Ltd.***Aston Court, Kingsmead Business Park***Frederick Place***High Wycombe, HP 11 1LA***United Kingdom***Tel: +441494 616126***Rx Only***LOT D493042603***. Cutting and Shaping bone including bones of the spine and cranium.

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code HBC·May 9, 2011

    Sterile Bone Cutting Burrs model S-5B-4 labeled in part:***S-5B-4***QTY: 1***5 mm Fluted Ball, 4-Series.***Use with***SHORT Attachments.***Use by 2016-03***ANSPACH***Manufacturer***Made in USA***The Anspach Effort, Inc.***4500 Riverside Drive***Palm Beach Gardens, FL 33410, USA***Tel: (800) 327 6887 / + 1 561 627 1080***EC REP***Anspach Europe Ltd.***Aston Court, Kingsmead Business Park***Frederick Place***High Wycombe, HP 11 1LA***United Kingdom***Tel: +441494 616126***Rx Only***LOT E173049623***. Cutting and Shaping bone including bones of the spine and cranium.

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code HBC·May 9, 2011

    Sterile Bone Cutting Burrs model QD8-4OVD labeled in part:***QD8-4OVD***QTY: 1***4 mm x 8 mm Diamond Oval. Use with***QD8 Attachments.***Use by 2016-03***ANSPACH***Manufacturer***Made in USA***The Anspach Effort, Inc.***4500 Riverside Drive***Palm Beach Gardens, FL 33410, USA***Tel: (800) 327 6887 / + 1 561 627 1080***EC REP***Anspach Europe Ltd.***Aston Court, Kingsmead Business Park***Frederick Place***High Wycombe, HP 11 1LA***United Kingdom***Tel: +441494 616126***Rx Only***LOT E173049563***. Cutting and Shaping bone including bones of the spine and cranium.

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code HBC·May 9, 2011

    Sterile Bone Cutting Burrs model SIL-7-9 labeled in part:***SIL-7-9***QTY: 1***9 mm Fluted Ball.***Use with B-Silber***Attachment.***Use by 2015-01***ANSPACH***Manufacturer***Made in USA***The Anspach Effort, Inc.***4500 Riverside Drive***Palm Beach Gardens, FL 33410, USA***Tel: (800) 327 6887 / + 1 561 627 1080***EC REP***Anspach Europe Ltd.***Aston Court, Kingsmead Business Park***Frederick Place***High Wycombe, HP 11 1LA***United Kingdom***Tel: +441494 616126***Rx Only***LOT D053031534***. Cutting and Shaping bone including bones of the spine and cranium.

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code HBC·May 9, 2011

    Brand Name: HFD100 Product Name: Head Fixation Device HFD100 Model/Catalog Number: 119695-000, 119629-000, 119630-000, 113803-000, 113803-600, 113802-000, 113802-600 Software Version: Not Applicable Product Description: The HFD100 Head Fixation Device provides rigid skeletal fixation within the optimal imaging envelope while introducing minimal artifacts in the acquired images. There are two different assemblies for the HFD100. The standard HFD100 is equipped with a table adapter for use with either the operating room table or the angiography table. For sites with a Hill-Rom TruSystem 7500 Hybrid Neuro MR Operating Table (ORT400), the HFD100 has a split block clamp assembly (Trumpf Mount Clamp Assembly) which connects directly to the table back section. The HFD100 system is also comprised of the linkage components to mount the skull clamp to the table adapter, and the 3-pin skull clamp. The linkage system is used to position the skull clamp in the necessary position, without colliding with the magnet bore. Component: Not a component.

    FDA Recall
    Open, Classified ·IMRIS Imaging Inc·Product code HBL·December 8, 2025

    IMRIS Operating Suite, InVision 3T Operating Suite, containing Siemens 3 Tesla MRI Magnet, Vida

    FDA Recall
    Open, Classified ·IMPRIS Imaging Inc·Product code LNH·September 30, 2025

    IMRIS Operating Suite, Neuro III-SV iMRI System, iMRX System, containing Siemens 3 Tesla MRI Magnet, Verio

    FDA Recall
    Open, Classified ·IMPRIS Imaging Inc·Product code LNH·September 30, 2025

    IMRIS Operating Suite, iMRI 3T S, containing Siemens 3 Tesla MRI Magnet, Skyra

    FDA Recall
    Open, Classified ·IMPRIS Imaging Inc·Product code LNH·September 30, 2025

    IMRIS Operating Suite, IMRIS iMRI 3T V, containing Siemens 3 Tesla MRI Magnet, vIDA

    FDA Recall
    Open, Classified ·IMPRIS Imaging Inc·Product code LNH·September 30, 2025

    GE Datex-Ohmeda Aisys, Datex-Ohmeda, Inc., a General Electric Company going to market as GE Healthcare, GE Healthcare PO Box 7550, Madison, WI. 53707-7550 Datex-Ohmeda Aisys Intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients. The device is intended for volume or pressure control ventilation. The Aisys is not suitable for use in a MRI environment.

    FDA Recall
    Terminated ·Datex - Ohmeda, Inc·Product code BSZ·August 28, 2008