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
View the latest FSNs
Ambu: King Vision video Laryngoscope
08 November 2019
Airway devices
Model: King Vision video Laryngoscope, KVLVA12
MHRA reference: 2019/011/021/291/007
Applied Medical: Python®, BARD Latex-free, Over-the-Wire latis®
November 2019
Vascular cannula and catheters
Model: A4EXX, A4GW6 and CE0XXXDR
MHRA reference: 2019/011/021/701/026
Edwards Lifesciences: HemoSphere Oximetry Cable
FCA 148
Monitors, patient
Model: HEMOXSC100
MHRA reference: 2019/011/021/701/027
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: 2019/011/020/701/017
impedimed: 292-DTE
08 November 2019
ECG
MHRA reference: 2019/011/021/291/001
Maquet (Getinge): Volista STANDOP, Volista TRIOP
20 November 2019
Lamps & lights
MHRA reference: 2019/004/024/487/017
Mavidon Medical Products: LemonPrep
13 September 2019
ECG
MHRA reference: 2019/011/025/291/010
Medtronic: O-arm™ O2 Imaging System
November 2019
X Ray, fluoroscopy systems
Model: BI-700-02000 O-arm O2 Base
MHRA reference: 2019/011/022/291/016
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: 2019/011/015/291/002
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
MHRA reference: 2019/011/021/291/006
Roche: Accu-Chek® Aviva, Performa BGM
06 November 2019
IVDs, self / home testing
MHRA reference: 2019/011/006/701/008
Siemens Healthineers: Cios Alpha
November 2019
X ray, fluoroscopy systems
Model: Cios Alpha systems with a specific material number
MHRA reference: 2019/011/026/601/001
Smith & Nephew: PROFIX 750 Gr. Mallet Cleaning&Sterilization Guide
C-2019-11
Surgical devices, non-powered
MHRA reference: 2019/011/026/701/011
Stanmore: Special (Custom) Tibial Augment (METS SMILES TKR)
22 November 2019
Joint prosthesis, knee
Model: N/A- Patient Specific Device
MHRA reference: 2019/011/025/291/014