BEUDAMED
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    RotoRest Delta Advanced Therapy System. The RotoRest Delta Advanced Kinetic Therapy System offers kinetic therapy for the most aggressive treatment of pulmonary complications.

    FDA Recall
    Terminated ·Arjo Hospital Equipment AB HANS MICHELSENSGATAN·Product code IKZ·December 3, 2014

    The Rotoprone therapy System is an advanced patient care system for the treatment and prevention of pulmonary complications. The Rotoprone Therapy System provides up to 62 degrees in both prone and supine positions as well as Trendelenburg/Reverse Trendelenburg positioning. Product Usage: Use of the Rotoprone Therapy System is indicated for patients with severe acute respiratory distress syndrome (ARDS). These are critical patients who are at higher risk of cardiac arrest and mortality. Placing a patient in the prone position may reopen collapsed airways and thus improve pulmonary gas exchange and respiratory mechanics.

    FDA Recall
    Terminated ·ArjoHuntleigh Inc.·Product code IKZ·September 11, 2013

    Easi-Care Gait Belt Metal Buckle (54", 60", and 72" lengths)

    FDA Recall
    Terminated ·Kinsman Enterprises Inc·Product code IKZ·September 10, 2021

    RotoProne powered patient rotation bed, part #209500, distributed by Kinetic Concepts, Inc., San Antonio, TX.

    FDA Recall
    Terminated ·Kinetic Concepts, Inc·Product code IKZ·January 24, 2005

    KCI RotoProne Critical Care Therapy System buckles for securing patient to the surface during proning therapy, Model 209500. Indicated for treatment and prevention of pulmonary complications.

    FDA Recall
    Terminated ·KCI USA, Inc.·Product code IKZ·February 18, 2011

    XPRT Therapy Mattress Systems: Model # 2950-000-000 with Dartex urethane-coated nylon cover (deluxe cover); and Model # 2950-000-001 with nylon cover without coating (standard cover). Responsible firm on the label: Manufactured for STRYKER MEDICAL, 6300 South Sprinkle Road, Kalamazoo, MI USA 49001-9799, 1-800-327-0770. The unit consists of a sleep surface, an integrated valve box located in the head of the mattress, a pump box located under the foot of the mattress and a color touch screen controller that can be mounted to either side of the pump box at the foot end of the mattress.

    FDA Recall
    Terminated ·Gaymar Industries Inc·Product code IKZ·October 25, 2004

    RotoProne Therapy System, Model 209500, Device List Number E232632 Product is designed to allow patients to be mechanically rotated to the prone position and provides kinetic therapy to patients. It is intended for the treatment and prevention of pulmonary complications associated with immobility.

    FDA Recall
    Terminated ·KCI USA, Inc.·Product code IKZ·September 9, 2010

    Rotoprone Therapy System. The Rotoprone Therapy System is an advanced patient care system for the treatment and prevention of pulmonary complications.

    FDA Recall
    Terminated ·Arjo Hospital Equipment AB HANS MICHELSENSGATAN·Product code IKZ·December 3, 2014

    KCI TriaDyne Proventa Critial Care Therapy System, manufactured by Kinetic Concepts, Inc., San Antonio, Texas 78219. Model number 308900

    FDA Recall
    Terminated ·Kinetic Concepts, Inc·Product code IKZ·March 22, 2004

    ARJOHUNTLEIGH GETINGE GROUP, RotoProne Therapy System, Model Number 209800

    FDA Recall
    Terminated ·Arjohuntleigh Magog 2001 Rue Tanguay Magog Canada Quebec·Product code IKZ·December 19, 2018

    TriaDyne Proventa Critical Care Therapy System. The TriaDyne Proventa Critical Care Therapy System provides a comprehensive system of pulmonary and skin care therapies for the critically ill, immobilized patient.

    FDA Recall
    Terminated ·Arjo Hospital Equipment AB HANS MICHELSENSGATAN·Product code IKZ·December 3, 2014

    OsteoBridge Intremedullary Knee Arthrodesis (IKA) nails

    FDA Recall
    Terminated ·Merete Medical GmbH Alt-Lankwitz 102 Berlin Germany·Product code HSB·September 18, 2020

    OsteoBridge Intremedullary Knee Arthrodesis (IKA) nails

    FDA Enforcement
    Class II ·Terminated·Merete Medical GmbH·November 18, 2020

    Cisco brand HealthPresence, version 2.1; Model/Catalog Number: CHP-ENTPRSYR2.I-K9; Product is manufactured and distributed by Cisco Systems, Inc. San Jose, CA Cisco HealthPresence, version 2 is intended for remote consultation of patients with a healthcare provider. Cisco HealthPresence enables remote collaboration between a physician and a patient by providing: high-definition video and advanced audio; transmission and display of third-party medical device data; integration with third party EMR: scheduling: and other software applications for remote consultations and exams. Cisco Health Presence is not intended for use in emergency situations. Cisco HealthPresence is not intended for use in active patient monitoring or alarming.

    FDA Enforcement
    Class II ·Terminated·Cisco Systems Inc·September 5, 2012

    Cisco brand HealthPresence, version 2.1; Model/Catalog Number: CHP-ENTPRSYR2.I-K9; Product is manufactured and distributed by Cisco Systems, Inc. San Jose, CA Cisco HealthPresence, version 2 is intended for remote consultation of patients with a healthcare provider. Cisco HealthPresence enables remote collaboration between a physician and a patient by providing: high-definition video and advanced audio; transmission and display of third-party medical device data; integration with third party EMR: scheduling: and other software applications for remote consultations and exams. Cisco Health Presence is not intended for use in emergency situations. Cisco HealthPresence is not intended for use in active patient monitoring or alarming.

    FDA Recall
    Terminated ·Cisco Systems Inc·Product code NSX·July 23, 2012

    EZ Derm Porcine Xenograft, labeled as the following: a. EZ Derm 3x4 (8x10 cm) Non-Perforated, Part Number: 131703-03; b. EZ Derm 7 x 18 (17 x 46 cm) Non-Perforated, Part Number: 131704-03; c. EZ Derm 2 x 2 (5 x 5 cm) Non-Perforated, Part Number: 131705-03; d. EZ Derm 3 x 48 (8 x 122 cm) Perforated, Part Number: 131710-03; e. EZ Derm 3 x 24 (8 x 61 cm) Perforated, Part Number: 131711-03; f. EZ Derm 3 x 12 (8 x 30 cm) Perforated, Part Number: 131712-03; g. EZ Derm 3 x 4 (8 x 10 cm) Perforated, Part Number: 131713-03; h. EZ Derm 7 x 18 (17 x 46 cm) Perforated, Part Number: 131714-03; i. EZ Derm 2 x 2 (5 x 5 cm) Perforated. Part Number: 131715-03 Product Usage: EZ Derm is a porcine derived xenograft in which the collagen has been cross linked with an aldehyde. EZ Derm (porcine xenograft) can be used for partial thickness skin loss injuries. Use of EZ Derm for burns, donor sites and chronic vascular ulcers reduces pain and fluid loss. EZ Derm can also be used as a temporary cover, or test graft, prior to auto grafting and as a protective covering over perforated auto grafts.

    FDA Recall
    Terminated ·Molnlycke Health Care, Inc·Product code KGN·March 26, 2019

    EZ Derm Porcine Xenograft, labeled as the following: a. EZ Derm 3x4 (8x10 cm) Non-Perforated, Part Number: 131703-03; b. EZ Derm 7 x 18 (17 x 46 cm) Non-Perforated, Part Number: 131704-03; c. EZ Derm 2 x 2 (5 x 5 cm) Non-Perforated, Part Number: 131705-03; d. EZ Derm 3 x 48 (8 x 122 cm) Perforated, Part Number: 131710-03; e. EZ Derm 3 x 24 (8 x 61 cm) Perforated, Part Number: 131711-03; f. EZ Derm 3 x 12 (8 x 30 cm) Perforated, Part Number: 131712-03; g. EZ Derm 3 x 4 (8 x 10 cm) Perforated, Part Number: 131713-03; h. EZ Derm 7 x 18 (17 x 46 cm) Perforated, Part Number: 131714-03; i. EZ Derm 2 x 2 (5 x 5 cm) Perforated. Part Number: 131715-03 Product Usage: EZ Derm is a porcine derived xenograft in which the collagen has been cross linked with an aldehyde. EZ Derm (porcine xenograft) can be used for partial thickness skin loss injuries. Use of EZ Derm for burns, donor sites and chronic vascular ulcers reduces pain and fluid loss. EZ Derm can also be used as a temporary cover, or test graft, prior to auto grafting and as a protective covering over perforated auto grafts.

    FDA Enforcement
    Class II ·Terminated·Molnlycke Health Care, Inc·May 8, 2019

    First Check 7 Panel Drug Cup: (AMP/COC/MDMA/MET/OPI/PCP/THC); AMT Item Number 990100B

    FDA Recall
    Terminated ·Ameditech Inc·Product code DKZ·August 18, 2020

    Triage Drugs of Abuse Panel, Model Number: 95000. Is an immunoassay test kit used for the qualitative determination of the presence of the major metabolites of drugs of abuse in urine.

    FDA Recall
    Terminated ·Biosite Inc·Product code DKZ·November 6, 2008

    Calloway LabsMulti-Drug 9 Panel Assay A rapid, one step screening test for the simultaneous for the qualitative detection of multiple drugs and drug metabolites in human urine.

    FDA Recall
    Terminated ·Alere San Diego·Product code DKZ·June 10, 2011