Field safety notices - 1 to 5 june 2015


Field safety notices - 1 to 5 june 2015

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FIELD SAFETY NOTICES - 1 TO 5 JUNE 2015 List of field safety notices (FSNs) from medical device manufacturers from 1 to 5 June 2015. CONTENTS * Overview * Latest FSNs * Aesculap: S4C occiput


torque wrench f/set screw * Alcon Laboratories: Alcon Accurus standalone vitreous probe packs * Astraia software: astraia FMF - first trimester risk screening for trisomy 21 * Bio-Rad


Medical Diagnostics: Biotestcell-I11 * Brahms, part of Thermofisher Scientific: BRAHMS PCT direct * Edwards Life Sciences: EV1000 NI heart reference sensor * Edwards Life Sciences *


Fresenius Medical Care. CRIT-LINE® blood chamber * GE Healthcare Integrated IT Solutions: Centricity PACS-IW with universal viewer * Integra NeuroSciences: Camino® intracranial pressure


monitoring catheter * Intuitive Surgical: 420343-01 420343-02 * Lohmann & Rauscher * One Lambda: Lambda Cell Trays™ * Optimedica Corporation: Catalys precision laser system * Philips:


Expression MRI patient monitoring system * Roche Diagnostics: S3 fluid pack A * Siemens Healthcare Diagnostics: RAPIDLab 1260 and RAPIDLab 1265 * Sorin Group: Heating unit, pad, water,


system * Stryker Instruments: TARGET 360 SOFT 3.5MM X 10CM, TARGET 360 NANO 1.5MM X 4CM, TARGET 360 NANO 1.0MM X 3C, TARGET 360 SOFT 6.0MM X 15CM, TARGET 360 ULTRA 3.5MM X 8CM. * Teleflex:


Hudson RCI SHERIDAN SHER-I-BRONCH endobronchial tube * Thermo Fisher Scientific: TCAutomation™ /enGen™ Laboratory Automation System * Varian: VariSource™ iX Afterloader (console software)


OVERVIEW If you receive a field safety notice (FSN) from a manufacturer you must always act on it. MHRA publishes the following for information only. If you have a question about a


particular FSN contact the manufacturer. LATEST FSNS View the latest FSNs. AESCULAP: S4C OCCIPUT TORQUE WRENCH F/SET SCREW 1 June 2015 Surgical instruments, implant Model: FW103R MHRA


reference: 2015/006/001/701/022 ALCON LABORATORIES: ALCON ACCURUS STANDALONE VITREOUS PROBE PACKS 3 June 2015 Phacoemulsification / vitrectomy systems MHRA reference: 2015/006/004/291/013


ASTRAIA SOFTWARE: ASTRAIA FMF - FIRST TRIMESTER RISK SCREENING FOR TRISOMY 21 22 May 2015 IVD, genetic testing Model: astraia software for women’s health MHRA reference: 2015/005/028/071/010


BIO-RAD MEDICAL DIAGNOSTICS: BIOTESTCELL-I11 1 June 2015 IVDs, blood transfusion MHRA reference: 2015/006/002/291/018 BRAHMS, PART OF THERMOFISHER SCIENTIFIC: BRAHMS PCT DIRECT 1 June 2015


IVDs, clinical chemistry MHRA reference: 2015/006/002/291/013 EDWARDS LIFE SCIENCES: EV1000 NI HEART REFERENCE SENSOR June 2015 Monitors, patient MHRA reference: 2015/006/003/071/002 EDWARDS


LIFE SCIENCES May 2015 Vascular cannula and catheters Model: IntraClude intra-aortic occlusion device, ICF100 MHRA reference: 2015/005/019/291/008 FRESENIUS MEDICAL CARE. CRIT-LINE® BLOOD


CHAMBER FA-2015-6; MDSS ref.: MDD15.065 Dialysis, blood lines MHRA reference: 2015/005/028/071/006 GE HEALTHCARE INTEGRATED IT SOLUTIONS: CENTRICITY PACS-IW WITH UNIVERSAL VIEWER Ref# 85386B


Picture archiving and communication system (PACS) Model: versions 5.0 through 5.0 Sp5.1 MHRA reference: 2015/006/002/291/017 INTEGRA NEUROSCIENCES: CAMINO® INTRACRANIAL PRESSURE MONITORING


CATHETER 29 May 2015 Monitors, patient Model: 110-4L MHRA reference: 2015/006/001/701/023 INTUITIVE SURGICAL: 420343-01 420343-02 2 June 2015 Surgical instruments, articulated holding Model:


EndoWrist® 5mm thoracic grasper MHRA reference: 2015/006/003/701/001 LOHMANN & RAUSCHER 28 May 2015 Surgical drapes, gowns, masks MHRA reference: 2015/005/029/051/007 ONE LAMBDA: LAMBDA


CELL TRAYS™ 27 May 2015 IVDs, immunology Model: LCT1W30, LCT1W60 MHRA reference: 2015/006/002/701/003 OPTIMEDICA CORPORATION: CATALYS PRECISION LASER SYSTEM May 2015 Therapy, lasers Model:


CATALYS-I MHRA reference: 2015/005/018/291/001 PHILIPS: EXPRESSION MRI PATIENT MONITORING SYSTEM 4 May 2015 Monitors, patient Model: 865214 MHRA reference: 2015/006/001/291/011 ROCHE


DIAGNOSTICS: S3 FLUID PACK A 21 May 2015 IVDs, extra laboratory testing MHRA reference: 2015/005/028/071/007 SIEMENS HEALTHCARE DIAGNOSTICS: RAPIDLAB 1260 AND RAPIDLAB 1265 May 2015 IVDs,


extra laboratory testing MHRA reference: 2015/005/006/601/002 SORIN GROUP: HEATING UNIT, PAD, WATER, SYSTEM 3 June 2015 Blood/fluid warming systems Model: 16-02-50, 16-02-80, 16-02-81,


6-02-82, 16-02-85, 16-02-95 MHRA reference: 2015/006/004/291/009 STRYKER INSTRUMENTS: TARGET 360 SOFT 3.5MM X 10CM, TARGET 360 NANO 1.5MM X 4CM, TARGET 360 NANO 1.0MM X 3C, TARGET 360 SOFT


6.0MM X 15CM, TARGET 360 ULTRA 3.5MM X 8CM. 29 May 2015 Implants, non-active, embolisation products Model: M0035473510, M0035421030, M0035421540, M0035423580, M0035476150 MHRA reference:


2015/006/001/291/001 TELEFLEX: HUDSON RCI SHERIDAN SHER-I-BRONCH ENDOBRONCHIAL TUBE 29 May 2015 Airway devices MHRA reference: 2015/006/002/291/004 THERMO FISHER SCIENTIFIC: TCAUTOMATION™


/ENGEN™ LABORATORY AUTOMATION SYSTEM May 2015 IVDs, clinical chemistry MHRA reference: 2015/005/011/601/001 VARIAN: VARISOURCE™ IX AFTERLOADER (CONSOLE SOFTWARE) 18 May 2015 Radiotherapy,


afterloading Model: H60 MHRA reference: 2015/005/029/701/001 UPDATES TO THIS PAGE Published 5 June 2015 Contents