Field Safety Notices - 27 February - 3 March 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 27 February - 3 March 2017
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
1stQ: Acrylic IOL, AddOn, Spherical, hydrophilic, clear
17 February 2017
Implants, non-active, intraocular
Model: A4SW00
MHRA reference:
AAP: VarioLoc cemented hip prosthesis, VarioLoc cementless hip prosthesis
25 February 2017
Joint prosthesis, hip
Model: all
MHRA reference:
Accuscience: Adson Disposable Bipolar Forceps 110mm straight with 1mm tip, McPherson Disposable Bipolar Forceps 110mm Straight with Straight O.5mm tip, 110mm Straight Micro Jeweller with Straight 0.5mm tip, Disposable Bipolar Forceps 200mm Straight with 1mm Tip
20 January 2017
Surgical, diathermy
MHRA reference:
Alere: Alere Afinion鈩� Lipid Panel Control
February-March 2017
IVDs, clinical chemistry
Model: Not applicable
MHRA reference:
Arrow International: ARROW庐 PICC Kits with Peel-Away Sheath Component.
24 February 2017
Vascular cannula and catheters
Model: ARROW 庐 PICC
MHRA reference:
Barco: MDRC-1119 Protective Front Cover
28 February 2017
Endoscopes, televisual systems
Model: C9826109
MHRA reference:
Becton Dickinson: BD Preset鈩� Eclipse鈩� ABG device
13 January 2017
Storage and collection devices
MHRA reference:
bioM茅rieux: VITEK庐 MS Instrument
24 February 2017
IVDs, bacteriology
Model: VITEK庐 MS Instrument, VITEK MS instrument for Japan
MHRA reference:
Boston Scientific: Lotus鈩� Valve System
23 February 2017
Implants, non-active, cardiovascular heart valves
Model: H749LTV230, H749LTV250, H749LTV270
MHRA reference:
Coloplast: Multi-organ procurement catheter
24 February 2017
Vascular cannula and catheters
Model: Multi-organ procurement catheter
MHRA reference:
Fresenius Medical Care: multiFiltratePRO
22 February 2017
Dialysis, haemofilters
Model: multiFiltratePRO; M20 5001
MHRA reference:
Hitachi: cobas庐 8100 automated workflow series (cobas 8100 BRF and URF)
20 February 2017
IVDs, clinical chemistry
Model: 07439954001; 07441657001
MHRA reference:
Hitachi: cobas 8000 modular analyzer series
22 February 2017
IVDs, clinical chemistry Model: cobas 8000 modular analyzer series: - cobas e 602 module (Model No. 05990378001) - cobas e 801 module (Model No. 07682913001)
MHRA reference:
Immucor: Panocell庐-20
20 February 2017
IVDs, blood transfusion MHRA reference:
Invivo: Flex Cardio Patient Monitoring System
December 2016
Monitors, patient
Model: 453564243591 XPer Flex Cardio 2010, 453564241901 XPer Flex Cardio 2010-Exchange
MHRA reference:
Medtronic: Endurant鈩� / Endurant II 鈩� Bifurcated Stent Graft Systems
March 2017
Implants, non-active, endoprostheses for aortic aneurysm Model: Various 23mm and 25mm mode
MHRA reference:
Medtronic: HeartWare Ventricular Assist System
1 March 2017
Implantable ventricular assist devices Model: 1400, 1401 and 1407
MHRA reference:
Nobel Biocare: Multi-unit abutment Plus CC RP 2.5mm
1 March 2017
Implants, dental
Model: 38882
MHRA reference:
Philips: V60 Ventilator
8 February 2017
Lung ventilators
Model: V60
MHRA reference:
Philips: BrightView SPECT, BrightView XCT, BrightView X 3/4 (Upgrade), BrightView X 3/8
23 February 2017
Nuclear medicine, PET-CT
MHRA reference:
Respironics California: V60 Ventilator
2 February 2017
Lung ventilators
Model: V60
MHRA reference:
Roche: Accu-Chek Insight
SB_RDC_2015_04
Infusion systems
Model: Accu-Chek Insight; 00700006889
MHRA reference:
Siemens: ADVIA庐 Chemistry Enzyme 2 Calibrator
February 2017
IVDs, clinical chemistry
MHRA reference:
Siemens: All artis systems with wireless foot switch
10 February 2017
X Ray, fluoroscopy systems
Model: 4787797, 4787805, 4787813
MHRA reference:
Siemens: Artis Q / Q.zen
9 February 2017
X Ray, fluoroscopy systems
Model: Artis Q systems with A100G generators
MHRA reference:
St. Jude Medical: Nanostim Leadless Cardiac Pacemaker (LCP) system
SJM Pre-Notification of Field Action Implants, active, pacemakers Model: Nanostim Leadless Cardiac Pacemaker (LCP) system MHRA reference:
Thermo Fisher Scientific: Parallel or Perpendicular Bypass VITROS 5.1
28 February 2017
IVDs, clinical chemistry
Model: Parallel Bypass, Type 1010; Perpendicular Bypass, Type 1011
MHRA reference:
Wassenburg Medical: WASSENBURG 庐WD440 Endoscope Washer-Disinfector
1 March 2017
Cssd wash/clean/drying equipment
Model: MY2010, 201, 202
MHRA reference:
Zimmer Biomet: Various Polyethylene Implants
24 February 2017
Joint prosthesis, knee MHRA reference: