Field Safety Notice: 23 to 27 September
List of field safety notices (FSNs) from medical device manufacturers from 23 to 27 September 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.
Abbott: Alinity hq Analyzer and Alinity hs Slide Maker Stainer Module
11 September 2019
IVDs, haematology
MHRA reference: 2019/009/016/701/003
Biomet (Zimmer): Various Biomet Products
25 September 2019
Joint prosthesis, hip
MHRA reference: 2019/009/026/487/001
Bruin Biometrics: SEM Scanner 200
1 September 2019
Diagnostic measurement and monitoring
200
MHRA reference: 2019/009/012/701/005
Convatec: Convex Two-Piece Skin Barriers i.e. Natura /Surfi
20 September 2019
Ostomy and continence equipment
MHRA reference: 2019/008/028/701/002
CooperSurgical: Embryology Heated Plate within the RI WitnessTM
19 August 2019
Laboratory equipment associated with IVF, cells, tissues
6-70-807; 6-70-807-A; 6-70-807-B
MHRA reference: 2019/009/023/487/002
Elekta: MOSAIQ®
September 2019
Radiotherapy
MHRA reference: 2019/009/025/701/017
FIM MEDICAL: VT1
1705
Optical, ophthalmic instruments & equipment
MHRA reference: 2019/009/024/487/001
GE: Achilles Express, Achilles Insight
GEHC Ref# 14019
Bone densitometry
MHRA reference: 2019/009/026/487/026
GN: Resound; Beltone
16 September 2019
Disabled peoples’ aids
Resound; Beltone
MHRA reference: 2019/009/024/487/002
Herida Healthcare: Herida Healthcare Lothian II Dynamic Mattress System
03 September 2019
Mattresses - active/passive and overlay
Lothian II Dynamic Mattress System (Product Code: LOTH-121)
MHRA reference: 2019/009/016/601/003
Hyphen BioMed: BIOPHENTM Normal Control Plasma
19 September 2019
IVDs, clinical chemistry
MHRA reference: 2019/009/025/487/025
Johnson & Johnson (Integra): Cerelink ICP Monitor
12 September 2019
Monitors, patient
826820
MHRA reference: 2019/009/026/487/004
LivaNova: VNS Therapy® SenTiva® Generator (Recall and Patient Management Recommendations Attached)
26 September 2019
Implants, active, stimulators, neuro
1000
MHRA reference: 2019/009/026/487/021
Medtronic: CareLink Programmer; CareLink Encore Programmer (UPDATE TO FSN 15-19 OCTOBER 2018)
September 2019
Implants, active, pacemakers
2090, 29901
MHRA reference: 2018/010/012/291/013
Novarad: NovaPACS
23 September 2019
Picture Archiving and Communication System (PACS)
MHRA reference: 2019/009/025/701/016
Philips: V60
30 August 2019
Lung ventilators
MHRA reference: 2019/009/023/487/037
Philips Health: Forte, Forte Jetstream AZ, Forte Jetstream, Diamond Select Forte, Diamond Select Forte
JETStream
19 September 2019
Nuclear medicine
Model: 882020 Forte, 882320 Forte Jetstream AZ, 882321 Forte Jetstream AZ upgrade, 882290 Forte Jetstream, 882291 Forte Jetstream upgrade, 889456 Diamond Select Forte, 889471 Diamond Select Forte JETStream
MHRA reference: 2019/009/024/487/035
Randox Laboratories: NEFA
23 September 2019
IVDs, clinical chemistry
FA115
MHRA reference: 2019/009/023/601/002
Roche Diagnostics: HCYS (Homocysteine Enzymatic Assay)
September 2019
IVDs, clinical chemistry
MHRA reference: 2019/009/024/701/009
Smith & Nephew Medical: RT-plus modular femoral block
19 September 2019
Joint prosthesis, knee
MHRA reference: 2019/009/019/701/020
Spacelabs: Xhibit Central Station
30 August 2019
Monitors, patient
Model 96102
MHRA reference: 2019/009/023/487/039
Tem Innovations (Instrumentation Laboratory): r ex-tem
22 July 2019
Assay/ reagent
MHRA reference: 2019/009/023/487/036