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: 2017/002/027/291/024
AAP: VarioLoc cemented hip prosthesis, VarioLoc cementless hip prosthesis
25 February 2017
Joint prosthesis, hip
Model: all
MHRA reference: 2017/002/028/291/009
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: 2017/002/024/291/024
Alere: Alere Afinion™ Lipid Panel Control
February-March 2017
IVDs, clinical chemistry
Model: Not applicable
MHRA reference: 2017/003/001/701/005
Arrow International: ARROW® PICC Kits with Peel-Away Sheath Component.
24 February 2017
Vascular cannula and catheters
Model: ARROW ® PICC
MHRA reference: 2017/002/027/291/006
Barco: MDRC-1119 Protective Front Cover
28 February 2017
Endoscopes, televisual systems
Model: C9826109
MHRA reference: 2017/002/028/701/012
Becton Dickinson: BD Preset™ Eclipse™ ABG device
13 January 2017
Storage and collection devices
MHRA reference: 2017/001/009/701/018
bioMérieux: VITEK® MS Instrument
24 February 2017
IVDs, bacteriology
Model: VITEK® MS Instrument, VITEK MS instrument for Japan
MHRA reference: 2017/002/024/291/016
Boston Scientific: Lotus™ Valve System
23 February 2017
Implants, non-active, cardiovascular heart valves
Model: H749LTV230, H749LTV250, H749LTV270
MHRA reference: 2017/002/023/291/004
Coloplast: Multi-organ procurement catheter
24 February 2017
Vascular cannula and catheters
Model: Multi-organ procurement catheter
MHRA reference: 2017/002/024/701/015
Fresenius Medical Care: multiFiltratePRO
22 February 2017
Dialysis, haemofilters
Model: multiFiltratePRO; M20 5001
MHRA reference: 2017/002/023/701/016
Hitachi: cobas® 8100 automated workflow series (cobas 8100 BRF and URF)
20 February 2017
IVDs, clinical chemistry
Model: 07439954001; 07441657001
MHRA reference: 2017/002/023/701/010
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: 2017/002/027/291/016
Immucor: Panocell®-20
20 February 2017
IVDs, blood transfusion MHRA reference: 2017/003/001/291/019
Invivo: Flex Cardio Patient Monitoring System
December 2016
Monitors, patient
Model: 453564243591 XPer Flex Cardio 2010, 453564241901 XPer Flex Cardio 2010-Exchange
MHRA reference: 2016/012/021/291/016
Medtronic: Endurant™ / Endurant II ™ Bifurcated Stent Graft Systems
March 2017
Implants, non-active, endoprostheses for aortic aneurysm Model: Various 23mm and 25mm mode
MHRA reference: 2017/003/001/291/026
Medtronic: HeartWare Ventricular Assist System
1 March 2017
Implantable ventricular assist devices Model: 1400, 1401 and 1407
MHRA reference: 2017/003/002/291/005
Nobel Biocare: Multi-unit abutment Plus CC RP 2.5mm
1 March 2017
Implants, dental
Model: 38882
MHRA reference: 2017/002/027/291/014
Philips: V60 Ventilator
8 February 2017
Lung ventilators
Model: V60
MHRA reference: 2017/003/001/291/006
Philips: BrightView SPECT, BrightView XCT, BrightView X 3/4 (Upgrade), BrightView X 3/8
23 February 2017
Nuclear medicine, PET-CT
MHRA reference: 2017/003/001/291/015
Respironics California: V60 Ventilator
2 February 2017
Lung ventilators
Model: V60
MHRA reference: 2017/002/028/291/010
Roche: Accu-Chek Insight
SB_RDC_2015_04
Infusion systems
Model: Accu-Chek Insight; 00700006889
MHRA reference: 2017/003/001/291/005
Siemens: ADVIA® Chemistry Enzyme 2 Calibrator
February 2017
IVDs, clinical chemistry
MHRA reference: 2017/002/024/601/004
Siemens: All artis systems with wireless foot switch
10 February 2017
X Ray, fluoroscopy systems
Model: 4787797, 4787805, 4787813
MHRA reference: 2017/002/027/601/001
Siemens: Artis Q / Q.zen
9 February 2017
X Ray, fluoroscopy systems
Model: Artis Q systems with A100G generators
MHRA reference: 2017/002/027/601/004
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: 2016/010/027/291/016
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: 2017/003/001/291/007
Wassenburg Medical: WASSENBURG ®WD440 Endoscope Washer-Disinfector
1 March 2017
Cssd wash/clean/drying equipment
Model: MY2010, 201, 202
MHRA reference: 2017/002/024/291/022
Zimmer Biomet: Various Polyethylene Implants
24 February 2017
Joint prosthesis, knee MHRA reference: 2017/002/024/701/016