BEUDAMED
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    STA - System Control N + P Product Usage: The STA -System Control N+P kit provides a normal plasma and an abnormal plasma intended for use as two control levels for the following assays performed on analyzers of the STAbrand name suitable to these reagents: -the Reagent 1 (STA-System Control N)is for the following tests: prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen (Clauss method), thrombin time (TT), Reptilase time, factors II, V, VII, VIII, IX, X, XI and XII, antithrombin (AT), protein C, protein S, plasminogen and antiplasmin. -the Reagent 2 (STA -System Control P) is for the tests as described above except thrombin time (TT) and Reptilase time. Do not use the STA -System Control N+P kit on STA Satellite for the control of the APTT performed with the STA-rTT kit.

    FDA Recall
    Terminated ·Diagnostica Stago, Inc.·Product code GGN·August 23, 2011

    Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code LLZ·August 12, 2021

    Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·October 13, 2021

    Diana Automated Compounding System, Diana Onco 3xx, Item No. ASN303 The Diana is an automated compounding device for the accurate, safe and efficient preparation of solutions by a pharmacist prior to delivery for infusion into patient.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·April 20, 2016

    GE Centricity PACS-IW versions 3.6.0 through 3.7.3.9 SP1, SP2, SP3 and 3.7.3 SPa10, Model Numbers: a) 2052831-00x b) 2050578-0xx c) 2090228-002 d) 2052782-00x

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code LLZ·May 22, 2019

    GE Centricity PACS-IW versions 3.6.0 through 3.7.3.9 SP1, SP2, SP3 and 3.7.3 SPa10, Model Numbers: a) 2052831-00x b) 2050578-0xx c) 2090228-002 d) 2052782-00x

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·June 19, 2019

    MYLA server HP Proliant: DL380-G8 and ML350-G6 version 3.xx computer application software. MYLA V3 is a computer application ("Middleware") based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s).

    FDA Enforcement
    Class II ·Terminated·bioMerieux, Inc.·May 27, 2015

    Ear Loop Procedure Masks, For one time use only, Glass-Free, Reorder No. 2201, packed in a cardboard box (unit box). Manufactured for dynarex Corporation, Brewster, NY 10509. Made in China. Product is labeled with a Latex-free symbol that states ''This product does not contain any natural rubber latex'' . A total of 50 masks are in one unit box, and 12 boxes are placed into one shipping carton/case.

    FDA Recall
    Terminated ·Dynarex Corporation·Product code FXX·December 31, 2002

    Ear Loop Procedure Masks With Plastic Shield, For one time use only, Glass-Free, Reorder No. 2202, packed in a cardboard box (unit box). Manufactured for dynarex Corporation, Orangeburg, NY 10962. Made in China. Product is labeled with a Latex-free symbol that states ''This product does not contain any natural rubber latex'' . A total of 50 masks are in one unit box, and 4 boxes are placed into one shipping carton/case.

    FDA Recall
    Terminated ·Dynarex Corporation·Product code FXX·December 31, 2002

    MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 2 MASKS, Item Code 2040

    FDA Recall
    Terminated ·AMD Medicom Inc.·Product code FXX·October 11, 2019

    VIPA Veronikis Intra-Fiberoptic Pelvic Assistant, Set Catalog No 350-370. VIPA Set Includes: VIPA Urethropexy Tip Catalog No. 350-374 (Also sold individually); VIPA Urethropexy Elbow Catalog No. 350-375 (also sold individually); VIPA Vaginal Cuff Tips (small) Catalog No. 350-376 (Also sold individually); VIPA Vaginal Cuff Tips (large) Catalog No. 350-378 (Also sold individually); VIPA Rectal Probe Catalog No. 350-380 (Also sold Individually); VIPA Fiber Optic Cable (Storz to ACMI Connection) Catalog No. 350-372 (Also sold individually). For use in Urethropexy Procedures and Paravaginal Repairs (accurate suture placement by illuminating the anatomy lateral to the bladder neck); in Sacrocolpopexy (steadies the vaginal vault and provides a suture platform with fiberoptic illumination); in Vaginal surgery (illuminates the rectum to visualize endometriosis lesions on the rectovaginal septum).

    FDA Recall
    Terminated ·Marina Medical Instruments Inc.·Product code EXX·April 9, 2009

    Comfort brand Ear-Loop Face Mask, Item #: 3100, Model Numbers: # 3100B, # 3100P, # 3100G, # 3100Y, # 3100W; Product is manufactured and distributed by Maytex Corporation, CA Ear-loop face mask for basic medical/dental procedures.

    FDA Recall
    Terminated ·Maytex Corp·Product code FXX·May 15, 2013

    Supergrade Earloop Masks, surgical mask; 50 masks per box; Distributed by Safco Dental Supply Co., Northbrook, IL 60062

    FDA Recall
    Terminated ·Safco Dental Supply Co. Inc.·Product code FXX·June 3, 2003

    Magellan Robotic System; Model No(s). 11132 and 11139. A steerable catheter control system used at clinical sites.

    FDA Recall
    Terminated ·Hansen Medical Inc·Product code DXX·March 18, 2015

    Magellan Robotic Catheter Accessory Kits, Model number MACC 50 and MACC80. Cardiology: The Hansen Medical Magellan System is a robotic control system that enables positioning and visualization of a Magellan Catheter and an off-the-shelf guide wire while allowing a physician to remain seated and away from the x-ray radiation source. The Accessory Kits contain disposable components that keep the Magellan Catheters and 3rd-party guide wires performing smoothly during system operation.

    FDA Recall
    Terminated ·Hansen Medical Inc·Product code DXX·March 25, 2016

    MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 3 MASKS, Item Code 2042

    FDA Recall
    Terminated ·AMD Medicom Inc.·Product code FXX·October 11, 2019

    Artisan brand Extend Control Catheter; An Steerable Guide Catheter; Component of Sensei X Robotic Catheter System; Model Number: 07546; Distributed and Manufactured by Hansen Medical, Inc, Mountain View, CA

    FDA Recall
    Terminated ·Hansen Medical Inc·Product code DXX·October 19, 2009

    Sensei X Robotic Catheter System, model numbers 02057 and 08257. - Set up joint (SUJ)mechanical clamp that secures the SUJ to the catheter laboratory table. Product Usage: The Sensei X Robotic Catheter System is an electromechanical software controlled system designed to facilitate navigation and control of Hansen Medicals robotically steerable catheters for collecting electrophysiological data within the heart atria with electro-anatomic mapping and recording systems.

    FDA Recall
    Terminated ·Hansen Medical Inc·Product code DXX·December 4, 2014