Field Safety Notices: 23 to 27 November 2020
List of field safety notices (FSNs) from medical device manufacturers from 23 to 27 November 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 FSNs
View a list of FSNs published since January 2020
View FSNs since November 2014. FSNs before this date are on the National Archives website
Aesculap - B Braun: Aesculap Univation X System
19 November 2020
Joint prosthesis, knee
Model: N0711, N0712, N0713, N0714, N0715, N0721, N0722, N0723,
MHRA reference: 2020/011/016/487/016
Baxter: Artis, Evosys, Integra, Innova
27 November 2020
Dialysis, haemodialysis
Model: ARTIS 230V 110635, EVOSYS 230V 110648, ARTIS AFBK 114389, ARTIS 230 PHYSIO 115323, ARTIS 230 PHYSIO LP 115324, ARTIS AFBK PHYSIO 115326, ARTIS 230V LP 115401, ARTIS 230V PHYSIO I 115962, ARTIS 230V PHYSIO II 955412 ARTIS 230V PHYSIO II LP 115964, ARTIS AFBK PHYSIO II 115966, ARTIS 230V PYSIO PLUS 955680, ARTIS 230 PHYSIO PLUS LP 955681 ARTIS AFBK PHYSIO PLUS 955683, INNOVA 230V DIACARD 101323, INNOVA 230 106911, INTEGRA EU/HDF AP 100319 INTEGRA EU/AP 103450, INTEGRA EU/DIACARD 101324, INTEGRA 106910
MHRA reference: 2020/011/026/291/003
Boston Scientific: LOTUS Edge Valve System
November 2020
Implants, non-active, cardiovascular heart valves
MHRA reference: 2020/011/016/487/004
Cook Medical: Flexor® Check-Flo® Introducer, Flexor® Tuohy-Borst Side-Arm Introducer (Shuttle Select®)
25 November 2020
Vascular cannula and catheters
MHRA reference: 2020/011/026/291/004
Depuy Synthes: RIA 2 (Reamer Irrigator Aspirator)
23 November 2020
Orthopaedic surgical instruments - cutting tools
MHRA reference: 2020/011/020/487/004
Galil Medical- Boston Scientific: IceFORCE™, IcePearl™, IceRod™, IceSphere™, IceSeed™, IceEDGE™ Cryoablation Needles and Prostate Cryoablation Kits
19 November 2020
Surgical, cryogenic
MHRA reference: 2020/011/020/291/001
Medtronic: Cobalt XT DR/VR MRI SureScan, Cobalt XT HF CRT-D MRI SureScan, Cobalt HF Quad CRT-D MRI SureScan, Crome VR/DR MRI SureScan
November 2020
Implants, active, defibrillators
Model: DDPA2D4, DTPB2QQ, DVPA2D4, DVPB3D1, DVPB3D4, DVPC3D4, DDPC3D4, DTPA2D4, DTPB2D4
MHRA reference: 2020/011/026/291/001
Nipro India Corporation: ELISIO™-H and ELISIO™-M
13 November 2020
Dialysis, haemodialysis
Model: ELI-17H-GIN ELI-19H-GIN ELI-19M-GIN
MHRA reference: 2020/011/025/601/005
Olympus: Several GF-EUS ultrasound endoscopes
20 November 2020
Endoscopes, flexible
Model: GF-UC140P-AL5, GF-UCT140-AL5, GF-UE160-AL5,, GF-UE260-AL5, GF-UCT260, GF-UCT180, GF-UE190, GF-UE290, GF-UC240P-AL5, GF-UCT240-AL5 , GF-UM20, GF-UM130, GF-UMQ130, GF-UMP230, CF-UMQ230, GF-UM240, GF-UMQ240, GF-UM160, GF-UC160P-OL5, GF-UCT160-OL5, GF-UM2000, GF-UC2000P-OL5, GF-UCT2000-OL5
MHRA reference: 2020/011/017/291/001
RaySearch Laboratories: RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5.0, RayStation 6.0, RayStation 7.0, RayStation 8A, RayStation 8B, RayStation 9A, RayStation 9B
RSL-D-61-422
Radiotherapy planning and verification systems
MHRA reference: 2020/011/018/291/012
Roche: cobas z 480 analyzer
19 November 2020
IVDs, viral microbiology
Model: 05200881001
MHRA reference: 2020/011/024/487/004
Siemens: syngo.via RT Image Suite, feature: Patient marking
August 2020
Computed tomography
Model: 10496180 and other
MHRA reference: 2020/007/030/601/001
Siemens: ARTIS icono and ARTIS pheno
November 2020
X Ray, fluoroscopy systems
MHRA reference: 2020/011/024/601/003
Siemens: SOMATOM Definition AS/Edge/Flash, Drive, Force
November 2020 (CT057/20/S)
Computed tomography
Model: 8098027, 10590000, 10430603, 10431700, 10742326, 10590100,
MHRA reference: 2020/011/024/601/007
Stryker: Everest® MI XT Tab Removal Tool
18 November 2020
Orthopaedic surgical instruments - Insertion/extraction tools
MHRA reference: 2020/011/012/291/001