Field Safety Notice: 8 to 12 July 2019
Summary List of field safety notices (FSNs) from medical device manufacturers from 8 to 12 July 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 FSN
Médicréa International: IMPIX C / IMPIX MANTA
20 June 2019
Spinal implants
MS1116120; B20171963
MHRA reference: 2019/007/010/228/002
Möller-Wedel: FS 2-21, FS 2-25 und FS 3-45
29 May 2019
Surgical equipment, miscellaneous
MHRA reference: 2019/007/011/121/001
Randox Laboratories: RX Modena
2 July 2019
IVDs, clinical chemistry
RX9000
MHRA reference: 2019/007/005/601/003
Randox Laboratories: Calibration Serum Level 3
05 July 2019
IVDs, clinical chemistry
CAL2351
MHRA reference: 2019/007/005/601/009
Samsung: General-purpose ultrasound imaging system
FSN-WS80A_190604-1, FSN-HS70A_190604-1
Ultrasound, imaging
WS80A, HS70A
MHRA reference: 2019/007/011/228/005
Smiths Medical: Deltec GRIPPER Needle
11 July 2019
Infusion & transfusion, administration sets
MHRA reference: 2019/007/010/228/011
Zimmer: Pulsavac Plus Wound Debridement System
08 July 2019
Surgical equipment, miscellaneous
MHRA reference: 2019/007/009/701/032