Field Safety Notice: 03 to 07 June 2019
List of field safety notices (FSNs) from medical device manufacturers from 3 to 7 June 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
Aesculap AG FSCA 234: DISP, FLEECE DRAPE F/GA419/GD417/GD421
06 June 2019
Surgical drapes, gowns, masks
MHRA reference: 2019/006/006/701/018
Aesculap AG: UNI-Graft® K DV (12 mm/15 cm)
06 June 2019
Implants, non active, surgical vascular grafts & patches
MHRA reference: 2019/006/006/701/019
AngioDynamics: Solero MTA System and Solero MTA Applicator
17 April 2019
Therapy tissue ablation
Model: H78712740000
MHRA reference: 2019/004/025/291/005
Beckman Coulter: Power Express, AU5800 Conn XL PW21
21 May 2019 IVDs, clinical chemistry
MHRA reference: 2019/005/024/601/006
DIAsource: VIP RIA (Vasoactive intestinal polypeptide)
04 May 2019
IVDs, clinical chemistry
MHRA reference: 2019/006/005/291/008
Diffuplast (Baxter): ExactaMix
05 June 2019
Feeding systems and tubes
Model: 1420.0D/5
MHRA reference: 2019/006/005/701/016
ES-Medical: C-10 Probetester
27 May 2019 Cssd wash/clean/drying equipment
MHRA reference: 2019/006/003/291/008
Edwards LifeSciences: IntraClude Intra-Aortic Occlusion Device
30 May 2019
Vascular cannula and catheters
Model: ICF100
MHRA reference: 2019/006/006/291/001
Fast Track Diagnostics: FTD Lyophilized products
04 June 2019
IVDs, viral microbiology
MHRA reference: 2019/006/005/291/005
GE: Senographe Pristina and Pristina Serena FMI 12283 Mammography MHRA reference: 2019/005/031/487/001
GE: Centricity Universal Viewer with CPACS Foundations
FMI 85452
Picture archiving and communication system (PACS)
MHRA reference: 2019/006/003/291/001
GE Healthcare: Vscan Extend
GEHC73088
Ultrasound, imaging
MHRA reference: 2019/005/029/701/050
Gambro (Baxter): Prismaflex System, Prismaflex 4.11, Prismaflex 5.0
17 May 2019
Dialysis, haemodialysis
Model: • 114870
MHRA reference: 2019/005/017/487/003
Hologic: Aptima Combo 2 Assay
June 2019
IVDs, bacteriology Aptima Combo 2 Assay
MHRA reference: 2019/006/004/601/00
LifeTech Scientific: Cera Plug Delivery Cable
15 May 2019
Implants, non active, embolisation products
Model: 3F delivery cable, being pre-assembled together with Plug
MHRA reference: 2019/005/022/487/005
Medtronic: GuardianTM Connect Application
May 2019
Continuous glucose monitoring systems (CGMS)
Model: CSS7200
MHRA reference: 2019/005/030/228/003
Nobel Biocare: Healing Abutment CC RP Ø3.6x5mm
PFA1910
Implants, dental
MHRA reference: 2019/005/024/701/010
Pega Medical: Simple Locking Intramedullary (SLIM) System
CPA420
Orthopaedic surgical instruments - Insertion/extraction tools
Model: SLM-HND100
MHRA reference: 2019/005/030/601/006
Philips: HeartStart MRx Defibrillator/Monitor
May 2019
Defibrillators, non-Implantable Model: 861288 (M3535A), 861289 (M3536A), 861464 (M3536M), 861465 (M3536MC), 861481 (M3536M2), 861482 (M3536M3), 861483 (M3536M4), 861484 (M3536M5), 861491 (M3536M6), 860396 (M3536M7), 860397 (M3536M8), 860398 (M3536M9), 861287 (M3539A) AC Power Module
MHRA reference: 2019/006/003/291/003
QIAGEN: QIAsymphony Filter Tips, 1500µl (1024)
31 May 2019
IVDs, viral microbiology
MHRA reference: 2019/006/003/701/013
Roche: Accu-Chek® Insight
SB_RDC_2019_02
Infusion systems
MHRA reference: 2019/006/006/701/023
Sacci Ryggsäckar AB: Sacci Infusion Thermo Bag
15 May 2019
Infusion & transfusion, administration sets
MHRA reference: 2019/005/021/487/004
Siemens Healthcare: I VDs, Extra Laboratory Testing
May 2019
IVDs, extra laboratory testing
MHRA reference: 2019/006/005/601/003
Telelfex Medical: Pleur Evac
05 June 2019
Chest drains and accessories
MHRA reference: 2019/006/005/701/009
Telelfex Medical: Auto Endo5 ML
24 May 2019
Clip appliers
MHRA reference: 2019/005/024/701/034