Field Safety Notices - 2 to 6 March 2020
Summary List of field safety notices (FSNs) from medical device manufacturers from 2 to 6 March 2020
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
C-RAD Positioning: C-RAD c4D software
28 January 2020
Radiotherapy planning and verification systems
MHRA reference:
Cristalens: concerning software
20 November 2019
Implants, non-active, intraocular
MHRA reference:
Dermosciences: Mela Peel kit, Mela Peel Forte kit / Dermaceutic
BR-2019-03- 16 January 2020
Substances for topical application (non-pharmaceutical)
Activa Peel bottle 12 ml
MHRA reference:
Dermosciences: TCA 12, TCA 15, TCA 18, TCA 20
16 January 2020
Substances for topical application (non-pharmaceutical)
Model: 30 ml bottle
MHRA reference:
Fast Track Diagnostics: Siemens Material Number 10921784/ 10921785
February 2020
IVDs, bacteriology
MHRA reference:
Horiba: Yumizen G DDi 2
21 February 2020
Coagulation
MHRA reference:
Karl Storz: Low pressure tube, for the central CO2 gas supply
26 February 2020
Surgical equipment, minimal access
UI001, UI002 und UI003
MHRA reference:
Medisoft: Medisoft Ophthalmology
26 February 2020
Optical, ophthalmic instruments & equipment
MHRA reference:
Medisoft: Medisoft Ophthalmology
27 February 2020
Optical, ophthalmic instruments & equipment
MHRA reference:
Molnlycke: Molnlycke Procedure Trays
20 February 2020
Surgical devices, non-powered
MHRA reference:
Omixon Biocomputing: Omixon HLA TWIN CE
05 March 2020
IVDs, Immunology
SW1
MHRA reference:
Pennine Healthcare: SYS-5212
05 March 2020
Surgical equipment, miscellaneous
Yankauer Sucker Set, 2.0m, 5mm, Neuroflex - SYS-5212
MHRA reference:
Philips: TRx4851A 2.4 GHz IntelliVue Tele TRX or TRx4841A 1.4 GHz IntelliVue Tele TRX When used in combination with the Patient Information Center (PIC) iX
19 March 2020
Monitors, patient
Model: 862231 or 862439 when used with 866389, 866390
MHRA reference:
R82: Chest support for Rabbit/Rabbit Up/Mustang
04 March 2020
Supportive seating
MHRA reference:
RaySearch Laboratories: RayStation
03 March 2020
Radiotherapy planning and verification systems
RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 4.9
MHRA reference:
Siemens: N Latex CDT Kit
February 2020
IVDs, clinical chemistry
MHRA reference:
ViCentra B.V: Kaleido Insulin Cartridge
04 March 2020
Infusion systems
MHRA reference:
Zimmer: Anatomical Shoulder Trial Humeral PE-Insert 40-0
28 February 2020
Joint prosthesis, shoulder
Model: 01.04239.730
MHRA reference: