Field Safety Notice: 27 to 30 August 2019
List of field safety notices (FSNs) from medical device manufacturers from 27 to 30 August 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
AGFA: DR 800
VR0000638
X Ray, genera
MHRA reference: 2019/008/028/701/016
Becton Dickinson: BD FACSLyric™ Flow Cytometer
August 2019
IVDs, cytopathology & histopathology
Model: BD FACSLyric™ Flow Cytometer
MHRA reference: 2019/008/027/701/031
Edwards Life Sciences: IntraClude Intra-Aortic Occlusion Device
FCA 125
Vascular cannula and catheters
Model: ICF100
MHRA reference: 2019/001/021/291/001
GE: Giraffe Bedded Warmers, Panda iRes Warmers
32067-A
Infant incubators
MHRA reference: 2019/008/029/487/006
Medicina: Medicina IV Syringe
22 August 2019
Injection devices
Model: IVS03
MHRA reference: 2019/008/022/601/002
Medline International: Towel, surgical
14 August 2019
Basic dressings, absorbents, swabs, procedure packs
MHRA reference: 2019/008/028/291/003
Medtronic: StealthStation Cranial 3.x Software; StealthStation S8 Cranial Software
August 2019
Surgical navigation system and accessories
MHRA reference: 2019/008/028/291/002
Pivotal Health Solutions: Epidural Positioning Device
27 August 2019
Injection devices
Model: EPD Package 2
MHRA reference: 2019/008/028/291/004
Radiometer: AQURE system
29 August 2019
IVDs, extra laboratory testing
Model: 933-599
MHRA reference: 2019/007/019/701/004
Radiometer: TCM5 FLEX/TCM5 BASIC
FAN 915-375
Diagnostic measurement and monitoring
MHRA reference: 2017/010/012/291/008
Rapid Medical:Endorectal Coils
16 August 2019
Magnetic resonance, equipment & accessories
Model: 01924, 01947, 01899, 01900, 01752
MHRA reference: 2019/008/012/701/017
Richardson Healthcare: C-Sorb
27 August 2019
Basic dressings, absorbents, swabs, procedure packs
MHRA reference: 2019/008/028/291/005
Roche: ALB2, BILT3
August 2019
IVDs, clinical chemistry
MHRA reference: 2019/008/028/701/001
Signus Medizintechnik: RABEA PEEK, zervikaler Cage gewinkelt 6x12x14mm 5°
8 August 2019
Spinal implants
MHRA reference: 2019/008/012/228/015