Field Safety Notice - 1 October to 5 October
List of field safety notices (FSNs) from medical device manufacturers from 1 October to 5 October
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
Alba Bioscience (Quotient): ALBAClone Anti-Leb
01 October 2018
IVDs, blood transfusion
Model: Z217
MHRA reference: 2018/010/001/601/007
Carl Zeiss
DE/CA08/3.1.58-02
IVDs, cytopathology & histopathology
Model: Cell Observer SD, DirectFRAP, Laser TIRF
MHRA reference: 2018/010/001/228/006
Covidien (Medtronic): Puritan Bennett 980 Ventilator
September 2018
Lung ventilators
MHRA reference: 2018/009/028/228/010
Etac: Rullstol Cross, parking brakes
30 September 2018
Wheelchairs, manual
MHRA reference: 2018/010/001/000/012
GMM General Medical Merate: FMI gear kit
FSCA-001-2018
X Ray, digital acquisition systems
MHRA reference: 2018/010/003/228/012
Heinz Kurz: KURZ-Precise Schneideblock ; 8000110 / 8000110
13 September 2018
Surgical devices, non-powered
MHRA reference: 2018/009/027/081/001
Integrum AB: Axor TC cENTRIC
28 September 2018
Prostheses
MHRA reference: 2018/010/001/000/013
LifeTech Scientific: Cera Plug
30 September 2018
Implants, non active, embolisation products
Model: LT-PLUG-04/LT-PLUG-06
MHRA reference: 2018/010/001/228/021
Medica Medizintechnik (Thera Trainer): THERA- Trainer Balo & Verto
24 July 2018
Diagnostic measurement and monitoring
MHRA reference: 2018/010/003/228/002
Medtronic: MiniMed 640G Insulin Pump
October 2018
Infusion systems
Model: MMT-1711, MMT-1712
MHRA reference: 2018/010/003/228/016
Molnlycke Health Care (Medtronic): Mon-a-Therm
August 2018
Vascular cannula and catheters
MHRA reference: 2018/009/028/228/014
Network Medical Products
08 August 2018
Implants, active, hearing
Model: 74-111-25
MHRA reference: 2018/009/028/601/009
Permobil (TI): Aero R, Aero T, Aero X, Aero Z, TRA, Twist, ZRA, 2GX
3032618-09/06/2018-001-C
Wheelchairs, manual
MHRA reference: 2018/009/021/291/021
Pro Med Instruments (Feinmechanik): DORO LUCENT® Base Unit ; - 1101.021, 1101.031, 1101.026
23 March 2018
Surgical instruments, articulated holding
MHRA reference: 2018/010/004/121/001
Randox Laboratories: Liquid Cardiac Controls
20 September 2018
IVDs, clinical chemistry
Model: CQ5051, CQ5052, CQ5053
MHRA reference: 2018/009/021/601/007
Siemens: Atellica Solution
September 2018
IVDs, clinical chemistry
Model: See additional information
MHRA reference: 2018/010/002/601/014
Siemens: Dimension Lipase/Dimension Vista Lipase
September 2018
IVDs, blood transfusion
Model: SMN# 10460277/ 10461745
MHRA reference: 2018/009/021/601/008
Siemens: RAPIDPoint 500 Blood Gas Analyzer
September 2018
IVDs, extra laboratory testing
MHRA reference: 2018/010/002/601/010
Siemens: Dimension Vista® System
September 2018
IVDs, blood transfusion
MHRA reference: 2018/010/003/228/010
TP Orthodontics: Generation 1 Jasper Vektor
30 September 2018
Dental appliances/instruments
MHRA reference: 2018/009/020/291/015
Welch Allyn: Connex Spot Monitor with Masimo® SpO2
14 September 2018
Monitors, patient
MHRA reference: 2018/009/028/228/011
Last updated 10 October 2018 + show all updates
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Mistaken name has been corrected from TP Orthodontics: Jasper Vektor into TP Orthodontics: Generation 1 Jasper Vektor
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First published.