Field Safety Notice: 25 to 29 November 2019
List of field safety notices (FSNs) from medical device manufacturers from 25 October to 29 November 2019.
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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Ambu: King Vision video Laryngoscope
08 November 2019
Airway devices
Model: King Vision video Laryngoscope, KVLVA12
MHRA reference:
Applied Medical: Python庐, BARD Latex-free, Over-the-Wire latis庐
November 2019
Vascular cannula and catheters
Model: A4EXX, A4GW6 and CE0XXXDR
MHRA reference:
Edwards Lifesciences: HemoSphere Oximetry Cable
FCA 148
Monitors, patient
Model: HEMOXSC100
MHRA reference:
GE: CARESCAPE Respiratory Modules (E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE) and the Airway Gas Option (N-CAiO)
FMI 36141
Anaesthetic machines & monitors
MHRA reference:
impedimed: 292-DTE
08 November 2019
ECG
MHRA reference:
Maquet (Getinge): Volista STANDOP, Volista TRIOP
20 November 2019
Lamps & lights
MHRA reference:
Mavidon Medical Products: LemonPrep
13 September 2019
ECG
MHRA reference:
Medtronic: O-arm鈩� O2 Imaging System
November 2019
X Ray, fluoroscopy systems
Model: BI-700-02000 O-arm O2 Base
MHRA reference:
Olympus: TJF-160R, TJF-140R, JF-140R, TJF-240, JF-240, JF-1T40, JF-TE3
19 November 2019
Endoscopes, flexible
Model: Duodenovideoscopes and Duodenofibroscopes
MHRA reference:
Philips Respironics: Trilogy Evo, Garbin Evo, LifeVent Evo2
November 2019
Lung ventilators
Model: DE2100X13B, DE2110X13B, EE2110X15B, ES2100X15B, ES2110X15B, EU2100X15B, EU2110X15B, FR2110X14B, GB2110X15B, IN2100X15B, IN2110X15B, IT2100X21B, LD2110X23B, ND2110X15B, SP2100X26B鈥�
MHRA reference:
Roche: Accu-Chek庐 Aviva, Performa BGM
06 November 2019
IVDs, self / home testing
MHRA reference:
Siemens Healthineers: Cios Alpha
November 2019
X ray, fluoroscopy systems
Model: Cios Alpha systems with a specific material number
MHRA reference:
Smith & Nephew: PROFIX 750 Gr. Mallet Cleaning&Sterilization Guide
C-2019-11
Surgical devices, non-powered
MHRA reference:
Stanmore: Special (Custom) Tibial Augment (METS SMILES TKR)
22 November 2019
Joint prosthesis, knee
Model: N/A- Patient Specific Device
MHRA reference: