Field Safety Notice - 5 to 9 March 2018
Summary List of field safety notices (FSNs) from medical device manufacturers from 5 to 9 March 2018
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
Boston Scientific: Capio™ SLIM Suture Capturing Device,
Capio™ Open Access Suture Capturing Device, Capio™ Standard Suture Capturing Device, Capio™ RP Suture Capturing Device, Uphold™ LITE Vaginal Support System with Capio™ SLIM, Pinnacle™ Anterior Pelvic Floor Repair Kit, Pinnacle LITE Pelvic Floor Repair Kit, Posterior with Capio SLIM
20 February 2018
Sutures
Model: M0068312321, M0068317050, M0068318150, M0068318170, M0068318250, M0068318261, M0068321010
MHRA reference: 2018/002/014/291/009
CareFusion Switzerland 317 Sárl: Alaris™/ Asena ™ GS,GH,CC,TIVA,PK, Syringe Pumps
March 2018
Infusion Systems
Model: all variants with prefix 8001, 8002, 8003, 8004, and 8005 (pumps manufactured before September 2008 only)
MHRA reference: 2017/010/003/701/009
Drager: Infinity Acute Care System (M540)
March 2018
Monitors, patient
MHRA reference: 2018/003/007/478/029
Geratherm Medical AG: Geratherm Patient Warming System UniqueTemp°
Recovery, Recovery Set 1; UniqueTemp° Pflegeset1
13 February 2018
Heating, Patient, Electrical Pads & Blankets
Model: Geratherm Patient Warming System UniqueTemp°
MHRA reference: 2018/003/008/291/006
Herco Wassertechnik: HP xxx D/x/x with Hercotherm Ring 9kW/5-4
12 February 2018
Dialysis, haemodialysis
MHRA reference:2018/003/002/478/012
Indes B.V: Quickie Wheel Drive
27 February 2018
Wheelchairs, powered
MHRA reference: 2018/003/002/291/005
Miltenyi Biotec: Tubing Set TPE LIFE 18 - TPE Line
26 February 2018
Apheresis
MHRA reference: 2018/003/002/291/002
Phadia AB: EliA anti-TSH-R well
FSN2018-01
IVDs, clinical chemistry
MHRA reference: 2018/001/031/601/004
Philips: Philips HeartStart FRx AED, Philips HS1 (Onsite) AED, Philips HS1 (Home) AED
16 February 2018
Defibrillators, non-implantable
Model: Philips HeartStart FRx AED – 861304, 861305
MHRA reference: 2018/003/005/291/002
Philips Medical Systems: Ingenuity Flex, Ingenuity CT, Ingenuity Core, Ingenuity Core128, Brilliance iCT, Brilliance iCT SP, Brilliance Big Bore (Oncology), Brilliance Big Bore (Radiology), Brilliance 16 Slice (Air), Brilliance 16 Slice (Power), Brilliance 40, Brilliance 64, IQon Spectral CT, Brilliance 6 Slice (Air), Brilliance 10 Slice (Air), Brilliance CT Private Practice CV config
08 February 2018
Computed tomography
Model: 728317, 728326, 728325, 728321, 728323, 728324, 728306, 728311, 728243, 728244, 728246, 728240, 728235, 728231, 728332, 728256, 728251, 728241
MHRA reference: 2018/003/005/291/014
Shippert Medical Technologies: TissuTrans Filtron 100
10 January 2018
Surgical Instruments, Minimal Access
MHRA reference: 2018/003/007/478/005
Siemens Healthcare Diagnostics Inc: Atellica Solution
February 2018
IVDs, clinical chemistry
Model: Atellica Solution IM 1300 Analyzer and Atellica Solution IM 1600 IM Analyzer
MHRA reference: 2018/003/006/601/005
Sofradim (subsidiary of Covidien): Versatex™ Monofilament Mesh 50 x 50 cm
March, 2018
Implants, non-active, abdominal & hernia mesh
Model: Versatex
MHRA reference: 2018/003/006/291/002
Zimmer Biomet: AIM Tibial Nail
28 February 2018
Joint prosthesis, knee
MHRA reference: 2018/003/002/478/011
Zimmer Biomet: Persona Partial Knee Spacer Blocks
6 March 2018
Orthopaedic surgical instruments - insertion/extraction tools
MHRA reference: 2018/003/007/478/028