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    Computed Tomography X-Ray System MX 8000 IDT 16; Model # 728120; Serial #'s: 2513, 2518, 3147, 3217, 3014, 3050, 3068, 3188, 3091, 3051, 3099, 3126, 3183, 3303, 2539 & 3056. Produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·July 27, 2010

    Philips MX8000 IDT CT Scanner, utilizing V2.1 software.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·April 2, 2003

    Philips MX8000 IDT CT Scanner System, 10 & 16 slice images.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·March 8, 2004

    Brilliance CT 16-Slice Water, System Code: 728245; Brilliance CT 10-Slice Water, System Code: 728250; Brilliance CT 6-Slice Water, System Code: 728255; MX8000 IDT 16, System Code: 728120 & MX8000 IDT 10, System Code: 728125 Computed Tomography X-ray systems. Distributed by Philips Medical Systems (Cleveland), Inc., 595 Miner Road, Cleveland, OH 44143 Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·March 12, 2013

    Brilliance CT 16-Slice Water, System Code: 728245; Brilliance CT 10-Slice Water, System Code: 728250; Brilliance CT 6-Slice Water, System Code: 728255; MX8000 IDT 16, System Code: 728120 & MX8000 IDT 10, System Code: 728125 Computed Tomography X-ray systems. Distributed by Philips Medical Systems (Cleveland), Inc., 595 Miner Road, Cleveland, OH 44143 Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·May 29, 2013

    Mx8000 IDT Whole Body Computed Tomography X-ray system Distributed by Philips Medical Systems, Highland Heights, OH 44143 The Brilliance Scanner are computed Tomography X-ray systems with multi-slice capability of up to 16 slices,which are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·September 18, 2012

    Mx8000 IDT Whole Body Computed Tomography X-ray system Distributed by Philips Medical Systems, Highland Heights, OH 44143 The Brilliance Scanner are computed Tomography X-ray systems with multi-slice capability of up to 16 slices,which are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·March 6, 2013

    Richard-Allan Scientific Paraffin Type 3 For in vitro diagnostic use. For use as an infiltration and embedding medium in histology. Thermo Scientific" Richard-Allan Scientific" Type 1, Type 3, Type 6, and Type 9 Paraffin is specifically designed for tissue processing and embedding of histological and cytological specimens. The product is a white solid at room temperature and a clear, colorless liquid when molten. The paraffin is highly quality controlled and can be used with both open and closed tissue processors. It is also compatible with all embedding centers and manual embedding techniques. The paraffin should be stored in a cool, dry place

    FDA Recall
    Terminated ·Richard-Allan Scientific Company·Product code IDT·February 16, 2016

    Li-Ion battery used in the Oxus Portable Oxygen Concentrator (POC), RS-00400. Also branded as Reliability Plus byDrive. The Portable Oxygen Concentrator is intended to deliver concentrated oxygen for adult patients with chronic pulmonary diseases.

    FDA Enforcement
    Class II ·Terminated·Oxus America, Inc.·February 13, 2013

    Misys Laboratory versions 5.2, 5.23, or 5.3 with ADT Interface to CoPathPlus.

    FDA Recall
    Terminated ·Sunquest Information Systems·Product code JQP·October 24, 2002

    Merge OrthoPACS software. The firm name on the label is Merge Healthcare, Hartland, WI.

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·June 28, 2017

    Merge PACS software. The firm name on the label is Merge Healthcare.

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·March 15, 2017

    CHS Custom Convenience Kit- (1) DT SCATPAD, DBL. TAPE, 12.5 X 16.5 Product Number: SEPA 402 (2) SCATPAD, 11 X 34 Product Number: SPA502

    FDA Enforcement
    Class II ·Terminated·Custom Healthcare Systems, Inc.·October 31, 2018

    CHS Custom Convenience Kit- (1) DT SCATPAD, DBL. TAPE, 12.5 X 16.5 Product Number: SEPA 402 (2) SCATPAD, 11 X 34 Product Number: SPA502

    FDA Recall
    Terminated ·Custom Healthcare Systems, Inc.·Product code LRO·August 13, 2018

    LANTIS Commander, LANTIS Commander 6.1, LANTIS 8.3 Commander, LANTIS System, LANTIS 6.1 Complete, LANTIS 6.1 Essential, LANTIS 8.3 Complete and LANTIS 8.3 Essential. Distributed by Siemens, Concord, CA Mfg by Impac Medical Systems, Sunnyvale, CA Electronic patient records management system

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code LMB·March 23, 2011

    Bemer-Set/ Pro-Set for the following models: REF. 410201 (BEMER Pro-Set), REF. 420201 (B.BOX Professional), REF. 420100 (B.BOX CLASSIC), REF. 410100 (BEMER Classic-Set), REF. 420200 (B.BOX Professional), and REF. 410200 (BEMER Pro - Set)

    FDA Enforcement
    Class II ·Terminated·BEMER INT. AG·February 17, 2021

    Roche cobas IT 1000 Product Usage: Intended Use: An electronic device intended to store, retrieve, and process laboratory data.

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code JQP·July 31, 2014

    Roche cobas IT 1000 Product Usage: Intended Use: An electronic device intended to store, retrieve, and process laboratory data.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·September 10, 2014

    Merge OrthoPACS software. The firm name on the label is Merge Healthcare, Hartland, WI.

    FDA Recall
    Terminated ·Merge Healthcare, Inc.·Product code LLZ·May 24, 2017

    SoftLab GUI Version 4.0.1.0 - 4.0.1.16, 4.0.2.0 - 4.0.2.10, 4.0.3.0 - 4.0.3.13, and 4.0.4.0 - 4.0.4.5. SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760. Manufacture/Distribution Dates: 4.0.1.0 - 08/06/04, 4.0.1.4 - 10/18/04, 4.0.1.5 - 01/18/04, 4.0.1.6 - 12/15/04, 4.0.1.7 - 01/10/05, 4.0.1.8 - 03/29/05, 4.0.1.9 - 05/06/05, 4.0.1.13 - 01/25/06, 4.0.1.14 - 03/26/07 4.0.1.15 - 05/02/07, 4.0.1.16 - 08/22/08, 4.0.2.0 - 04/08/05, 4.0.2.1 - 08/13/08, 4.0.2.2 - 06/06/05, 4.0.2.3 - 09/19/05, 4.0.2.4 - 09/19/05, 4.0.2.5 - 09/19/05, 4.0.2.7 - 02/13/06, 4.0.2.8 - 12/12/06, 4.0.2.9 - 02/20/08, 04.2.10 - 08/13/08, 4.0.3.2 - 05/17/06, 4.0.3.3 - 09/18/06, 4.0.3.4 - 09/27/06, 4.0.3.5 - 11/29/06, 4.0.3.6 - 06/22/07, 4.0.3.7 - 03/28/07, 4.0.3.8 - 06/22/07, 4.0.3.9 - 08/03/07, 4.0.3.10 - 08/24/07, 4.0.3.11 - 09/24/07, 4.0.3.12 - 03/07/08, 4.0.3.13 - 06/13/08, 4.0.4.2 - 02/22/08, 4.0.4.3 - 05/22/08, 4.0.4.4 - 07/28/08, 4.0.4.5 - 05/04/09. Intends to provide clients with an interface that links all clinical laboratory departments throughout the enterprise.

    FDA Recall
    Terminated ·SCC Soft Computer·Product code JQP·April 1, 2009