Field Safety Notice - 13 August to 17 August
List of field safety notices (FSNs) from medical device manufacturers from 13 August to 17 August
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
CIVCO Medical Instruments: Endocavity Needle Guide
30 July 2018
Surgical instruments, minimal access
Model: 676-144, 676-150
MHRA reference: 2018/008/016/701/017
Oridion (Medtronic): Capnostream™20 and Capnostream™20p Bedside Patient Monitors
16 August 2018
Monitors, patient
MHRA reference: 2018/008/016/291/024
Peek Vision: Peek Acuity Pro App PV_PAC_001
21 May 2018
Optical, ophthalmic instruments & equipment
MHRA reference: 2018/005/024/291/006
Regen Lab: Cellular Matrix, ArthroVisc40, SkinVisc40
10 July 2018
Implants, non active, injectable joint solutions
Model: ArthroVisc40; ARV-HA40-1, lot 025
MHRA reference: 2018/008/016/701/019
Sheffmed
07 August 2018
Surgical devices, non-powered
Model: Surgical instruments (multiple)
MHRA reference: 2018/008/014/291/017
Siemens: YSIO Systems
02 August 2018
X Ray, digital acquisition systems
MHRA reference: 2018/008/009/601/004
Siemens: Hematek Wright-Giemsa Stain Paks (SMN 10314755) / Hematek Modified Wright’s Stain Paks (SMN 10310965)
August 2018
IVDs, haematology
MHRA reference: 2018/008/010/601/001
Siemens: Patio Automation / StremaLAB Automation
August 2018
IVDs, clinical chemistry
MHRA reference: 2018/008/016/601/003
Siemens Healthineers: AXIOM ARTIS Systems
18 December 2018
X Ray, digital acquisition systems
Model: AXIOM Artis systems with a flat panel detector from a specific production batch
MHRA reference: 2018/001/008/601/005
Vision RT: AlignRT/AlignRT Plus/OSMS
09 August 2018
Radiotherapy planning and verification systems
MHRA reference: 2018/008/010/601/012
Zimmer Biomet: Hiploc Plate
17 August 2018
Osteosynthesis, bone plates
MHRA reference: 2018/008/016/701/021
Intersurgical: Manual Resuscitation Systems
07 June 2017
Resuscitators
MHRA reference: 2017/005/031/291/005