BEUDAMED
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    Coupler System II Mizuho Orthopedic Systems, Inc. Union City, CA 94587 The 5873 Coupler II is designed for use specifically with the Mizuho OSI Modular Base and the Spinal System Table Tops (AKA Jackson Spinal Table Top). The Coupler II mounts onto the Spinal Surgery Top by using the Spinal Top Adaptor Brackets. The 5873 Coupler II is used to allow positioning of a patient on the table utilizing either a skull clamp or horseshoe headrest for cranial stabilization or support during surgical procedures. The Coupler II can be accommodate either a radiolucent or aluminum skull clamp manufactured by Integra Life Sciences, referred to as a Mayfield clamp or the radiolucent or aluminum skull clamp referred to as the DORO which is manufactured by pro med instruments Inc.

    FDA Recall
    Terminated ·Mizuho Orthopedic Systems Inc·Product code FWZ·February 27, 2012

    MicroScan WalkAway-40 plus Instrument and MicroScan Walkaway-96 plus instrument access door hinge. Siemens Healthcare Diagnostics, Inc. in vitro diagnostic

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·July 9, 2014

    MicroScan WalkAway-40 plus Instrument and MicroScan Walkaway-96 plus instrument access door hinge. Siemens Healthcare Diagnostics, Inc. in vitro diagnostic

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code LRG·June 2, 2014

    Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative head height (when the IV fluid container is lower than the pump), and provides clinically accepted volumetric accuracy for all standard IV fluids, including blood, lipid, and Total Parenteral Nutrition (TPN). Model number: 621-100ES, 621-200ES, 621-300ES, and 621-400ES. To deliver a broad range of drugs with use with the B. Braun Medical Inc. Horizon Pump IV Sets.

    FDA Enforcement
    Class II ·Terminated·B Braun Medical, Inc.·September 18, 2013

    Plum A+ Hyperbaric Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; list number 11005 Product Usage: The Plum A+ Hyperbaric Infusion System is exclusively designed for hyperbaric therapy in monospace and multiplace chambers.

    FDA Enforcement
    Class II ·Terminated·Hospira Inc.·January 9, 2013

    Plum A+ Hyperbaric Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; list 11005. Hospira has received reports of incorrect seating of the regulator closer on the Plum A+ Infusion Pumps. If the regulator closer does not close the flow regulator actuator when the pump door is opened, and if the clinician has not engaged the clamp prior to opening the cassette door, unrestricted flow may occur.

    FDA Recall
    Terminated ·Hospira Inc.·Product code FRN·September 16, 2011

    Plum A+3 Triple Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following configurations: a) list 12348 - software version 10.3; b) list 12618 - software version 11.3; c) list 20678 - Hospira MedNet software; Product Usage: The Plum A+3 is a dual-line triple channel volumetric infusion system that provides precise delivery of multiple i.v. therapies across the general spectrum of clinical care, including ICU/CCU, OR, PACU, ER, Med/Surg, Pediatrics, Outpatient clinics and Home care

    FDA Enforcement
    Class II ·Terminated·Hospira Inc.·January 9, 2013

    Plum A+ Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following configurations: a) list 11971; b) list 11973 - software version 10.3; c) list 12391 - software version 11.3; d) list 20679 - Hospira MedNet Software e) list 20792 - Hospira MedNet Software; Product Usage: The Plum A+ Infusion System is a dual-line volumetric infusion pump that provides precise delivery of multiple i.v. therapies across the general spectrum of clinical care, including ICU/CCU, OR, PACU, ER, Med/Surg, Pediatrics, Outpatient clinics and Home care

    FDA Enforcement
    Class II ·Terminated·Hospira Inc.·January 9, 2013

    Welch Allyn ProBP 2400 Digital Blood Pressure Device #2400, REF 901096, Rx ONLY, Made in China --- Distributed by Welch Allyn Inc., 4341 State Street Road, Skaneateles Falls, NY 13153 --- Microlife Corporation 9F, 431, RuiGuang Road, NeiHu, Taipei, 11492, Taiwan, R.O.C. --- Microlife AG Espenstrasse 139 9443 Widnau, Switzerland

    FDA Enforcement
    Class II ·Terminated·Welch Allyn Inc·April 19, 2017

    Siemens Primus Linear Accelerator System, PRIMART MX Linear Accelerator System; PRIMUS Mid, Part Number:1940035 and PRIMART MX, Part Number: 5500371, Siemens Medical Solutions USA, Inc., Concord, CA

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·July 27, 2007

    Siemens Mevatron Linear Accelerator Systems: KD2, K 7767, K 8067, KD, KDS and KDS2, Mevatron KD2, Part No.: 1940753; Mevatron KD2, Part No.: 08515520; Mevatron KD2-Part No.: 9822685; Mevatron K 7767, Part No.: 5694302; Mevatron K 8067, Part No.: 5694401; Mevatron KD, Part No.: 8319857; Mevatron KDS, Part No.: 9401522; Mevatron KDS2, Part No.: 9411588; and Mevatron KDS2, Part No.: 9822693, Siemens Medical Solutions USA, Inc., Concord, CA

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·July 27, 2007

    Plum A+ Hyperbaric Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; list number 11005 Product Usage: The Plum A+ Hyperbaric Infusion System is exclusively designed for hyperbaric therapy in monospace and multiplace chambers.

    FDA Recall
    Terminated ·Hospira Inc.·Product code FRN·December 7, 2012

    Siemens Mevatron Linear Accelerator Systems; Mevatron M 7440, Part No.: 5672977; Mevatron M 6700, Part No.: 5693908; Mevatron M 6730, Part No.: 5694005; Mevatron M 7140, Part No.: 5694104; Mevatron M 7400, Part No.: 5694153; Mevatron M 7445, Part No.: 5694203; Mevatron M 6300, Part No.: 8317000; Mevatron M 6740, Part No.: 8319758; Mevatron MD, Part No.: 8319808; Mevatron ME, Part No.: 8490005; Mevatron MDX, Part No.: 8496200; Mevatron M2 6300, Part No.: 9401316; Mevatron M-2 6700, Part No.: 9401407; Mevatron M2 6740, Part No.: 9401506; Mevatron MD2, Part No.: 09401654; and Mevatron MDX-2, Part No.: 9401746 Siemens Medical Solutions USA, Inc., Concord, CA

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·July 27, 2007

    Plum A+ Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following configurations: a) list 11971; b) list 11973 - software version 10.3; c) list 12391 - software version 11.3; d) list 20679 - Hospira MedNet Software e) list 20792 - Hospira MedNet Software; Product Usage: The Plum A+ Infusion System is a dual-line volumetric infusion pump that provides precise delivery of multiple i.v. therapies across the general spectrum of clinical care, including ICU/CCU, OR, PACU, ER, Med/Surg, Pediatrics, Outpatient clinics and Home care

    FDA Recall
    Terminated ·Hospira Inc.·Product code FRN·December 7, 2012

    Plum A+3 Triple Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following configurations: a) list 12348 - software version 10.3; b) list 12618 - software version 11.3; c) list 20678 - Hospira MedNet software; Product Usage: The Plum A+3 is a dual-line triple channel volumetric infusion system that provides precise delivery of multiple i.v. therapies across the general spectrum of clinical care, including ICU/CCU, OR, PACU, ER, Med/Surg, Pediatrics, Outpatient clinics and Home care

    FDA Recall
    Terminated ·Hospira Inc.·Product code FRN·December 7, 2012

    Infusomat(R) Space Pump (US Version) with software version 686G030103 (commonly termed 'G03'), 686E030003, 686F030005, 686F030007, 686G030002, and 686G030102. Intended for use with adults, pediatrics and neonates and is intended to provide infusions of parenteral fluids/medications, blood and blood products indicated for infusion through FDA approved routes of administration.

    FDA Recall
    Terminated ·B. Braun Medical, Inc.·Product code FRN·March 23, 2012

    OSCOR ADELANTE BREEZEWAY 10F STRAIGHT S61CM D66CM Catalog # AB101218 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.

    FDA Recall
    Terminated ·Oscor, Inc.·Product code DYB·October 5, 2016

    OSCOR ADELANTE BREEZWAY 8F STRAIGHT S79CM D84CM Catalog # AB081211 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.

    FDA Recall
    Terminated ·Oscor, Inc.·Product code DYB·October 5, 2016

    OSCOR ADELANTE BREEZEWAY 10F C55 S61CM D66CM Catalog # AB101072 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.

    FDA Recall
    Terminated ·Oscor, Inc.·Product code DYB·October 5, 2016

    OSCOR ADELANTE BREEZEWAY 10F C55 S79CM D84CM Catalog # AB101076 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.

    FDA Recall
    Terminated ·Oscor, Inc.·Product code DYB·October 5, 2016