Field safety notices - 1 to 5 June 2015
List of field safety notices (FSNs) from medical device manufacturers from 1 to 5 June 2015.
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
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Aesculap: S4C occiput torque wrench f/set screw
1 June 2015
Surgical instruments, implant
Model: FW103R
MHRA reference:
Alcon Laboratories: Alcon Accurus standalone vitreous probe packs
3 June 2015
Phacoemulsification / vitrectomy systems
MHRA reference:
Astraia software: astraia FMF - first trimester risk screening for trisomy 21
22 May 2015
IVD, genetic testing
Model: astraia software for women鈥檚 health
MHRA reference:
Bio-Rad Medical Diagnostics: Biotestcell-I11
1 June 2015
IVDs, blood transfusion
MHRA reference:
Brahms, part of Thermofisher Scientific: BRAHMS PCT direct
1 June 2015
IVDs, clinical chemistry
MHRA reference:
Edwards Life Sciences: EV1000 NI heart reference sensor
June 2015
Monitors, patient
MHRA reference:
Edwards Life Sciences
May 2015
Vascular cannula and catheters
Model: IntraClude intra-aortic occlusion device, ICF100
MHRA reference:
Fresenius Medical Care. CRIT-LINE庐 blood chamber
FA-2015-6; MDSS ref.: MDD15.065
Dialysis, blood lines
MHRA reference:
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:
Integra NeuroSciences: Camino庐 intracranial pressure monitoring catheter
29 May 2015
Monitors, patient
Model: 110-4L
MHRA reference:
Intuitive Surgical: 420343-01 420343-02
2 June 2015
Surgical instruments, articulated holding
Model: EndoWrist庐 5mm thoracic grasper
MHRA reference:
Lohmann & Rauscher
28 May 2015
Surgical drapes, gowns, masks
MHRA reference:
One Lambda: Lambda Cell Trays鈩�
27 May 2015
IVDs, immunology
Model: LCT1W30, LCT1W60
MHRA reference:
Optimedica Corporation: Catalys precision laser system
May 2015
Therapy, lasers
Model: CATALYS-I
MHRA reference:
Philips: Expression MRI patient monitoring system
4 May 2015
Monitors, patient
Model: 865214
MHRA reference:
Roche Diagnostics: S3 fluid pack A
21 May 2015
IVDs, extra laboratory testing
MHRA reference:
Siemens Healthcare Diagnostics: RAPIDLab 1260 and RAPIDLab 1265
May 2015
IVDs, extra laboratory testing
MHRA reference:
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:
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:
Teleflex: Hudson RCI SHERIDAN SHER-I-BRONCH endobronchial tube
29 May 2015
Airway devices
MHRA reference:
Thermo Fisher Scientific: TCAutomation鈩� /enGen鈩� Laboratory Automation System
May 2015
IVDs, clinical chemistry
MHRA reference:
Varian: VariSource鈩� iX Afterloader (console software)
18 May 2015
Radiotherapy, afterloading
Model: H60
MHRA reference: