Field Safety Notice: 25 to 29 March
List of field safety notices (FSNs) from medical device manufacturers from 25 to 29 March.
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
ALCIS: Dental Arch
21 February 2019
Dental appliances / instruments
Model: 2099-AS
MHRA reference: 2019/003/022/291/005
AngioDynamics: NanoKnife Single Electrode Probe
22 March 2019
Therapy tissue ablation
MHRA reference: 2019/003/028/291/011
Arjo: Arjo Disposable Flite Clip Sling
04 April 2019
Hoists and slings
MFA1000M-XL-L1
MHRA reference: 2019/003/019/601/001
BioFire Diagnostics: FilmArray® Blood Culture Identification (BCID) Pan
25 March 2019
IVDs, bacteriology
RFIT-ASY-0127 / RFIT-ASY-0126
MHRA reference: 2019/003/026/291/003
BIOMERIEUX: VITEK® 2: AST-N254, AST-N330, AST-N371 test kits
25 March 2019
IVDs, bacteriology
MHRA reference: 2019/003/022/291/010
Brainlab: RT Elements
11 March 2019
Radiotherapy planning and verification systems
MHRA reference: 2019/003/026/701/002
Buhlmann Laboratories: IBDoc, component: IBDoc Portal, version 3.1.9
21 March 2019
IVDs, clinical chemistry
MHRA reference: 2019/003/022/701/012
Covidien (Medtronic): Endo Clinch™ II Auto Suture™ Grasper, Endo Grasp™ Grasper
March 2019
Surgical Instruments, Articulated Holding
Endo Clinch™ II Auto Suture™ Grasper - 174317, Endo Grasp™ Grasper – 173030
MHRA reference: 2019/003/025/291/006
Christoph Miethke: Ventricular Catheter
25 March 2019
Cerebrospinal fluid drainage, external
FV074P
MHRA reference: 2019/003/027/291/006
Direct Healthcare Services: Dyna-Form Mercury Advance
15 March 2019
Mattresses - active/passive and overlays
MHRA reference: 2018/010/010/206/001
Draeger: Breathing circuits VentStar Helix
March 2019
Breathing system components
MHRA reference: 2019/003/027/291/003
EBR Systems: WiSE CRT Transmitter
21 March 2019
Implants, Active, Intracardiac (leadless)
4100
MHRA reference: 2019/003/025/291/009
GE Medical Systems: Discovery NM 630, Discovery NM/CT 670 CZT, Discovery NM/CT 670 DR, Discovery
NM/CT 670 ES, Optima NM/CT 640, NM 830, NM/CT 850, NM/CT 860, NM/CT 870 CZT, NM/CT 870 DR.
FMI 40885
Nuclear medicine
MHRA reference: 2019/003/027/291/007
Gambro (Baxter): U9000
25 March 2019
Dialysis, haemodialysis
112062
MHRA reference: 2019/003/025/291/023
Limacorporate: Physica ZUK All poly tibial components
25 March 2019
Joint prosthesis, knee
MHRA reference: 2019/003/025/701/013
Nobel Biocare
27 March 2019
Orthopaedic surgical instruments - Insertion/extraction tools
MHRA reference: 2019/003/028/291/003
Olympus: EVIS LUCERA DUODENOVIDEOSCOPE
29 March 2019
Endoscopes, flexible
TJF-260V / JF-260V
MHRA reference: 2019/003/027/291/018
Ortho-Clinical: VITROS XT 7600
21 March 2019
IVDs, clinical chemistry
MHRA reference: 2019/003/022/601/003
O-Two: o_two e700, o_two e600, and o_two e500
04 March 2019
Lung ventilators
MHRA reference: 2019/002/008/487/008
Philips: - MultiDiagnost Eleva
- UroDiagnost Eleva
- OmniDiagnost Classic
- OmniDiagnost-Eleva
26 February 2019
X Ray, fluoroscopy systems
Model: - 708032: MultiDiagnost Eleva
- 708033: UroDiagnost Eleva
- 708034: MultiDiagnost Eleva with Flat Detector
- 708035: MultiDiagnost Eleva with Flat Detector
- 708036: MultiDiagnost Eleva
- 708037: MultiDiagnost Eleva with Flat Detector
- 708038: MultiDiagnost Eleva w Flat Detector
- 70859: OmniDiagnost Classic
- 708023: OmniDiagnost Classic
- 708024: OmniDiagnost Classic
- 708025: OmniDiagnost Classic
- 708026: OmniDiagnost-Eleva
- 708027: OmniDiagnost-Eleva
- 708028: OmniDiagnost-Eleva
MHRA reference: 2019/003/027/291/004
R82: Wombat Living
27 March 2019
Supportive seating
Model: Wombat Living size 3
MHRA reference: 2019/003/027/291/017
Randox Laboratories: G-6-PDH Control Deficient and Normal
21 March 2019
IVDs, clinical chemistry
PD2617, PD2618
MHRA reference: 2019/003/027/601/003
Roche: ProCell II M 06908799190 N/A
cobas e 801 module 07682913001 N/A
cobas e 801 analytical unit 08454345001
12 March 2019
IVDs, clinical chemistry
MHRA reference: 2019/003/022/291/001
Roche: cobas p507, cobas p701 post-analytical unit
20 March 2019
IVDs, clinical chemistry
MHRA reference: 2019/003/025/701/017
Siemens: Cios Spin
27 February 2019
X Ray, fluoroscopy systems
MHRA reference: 2019/003/026/601/007
Siemens: Cios Alpha VA20 Systems
20 February 2019
X Ray, fluoroscopy systems
MHRA reference: 2019/003/021/601/006
Updates to this page
Last updated 2 April 2019 + show all updates
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Corrected link to FSN for ProCell II M, cobas e 801 module and cobas e 801 analytical unit.
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First published.