Field Safety Notice: 18 to 22 November
List of field safety notices (FSNs) from medical device manufacturers from 18 to 22 November 2019.
Overview
Latest FSNs
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Aidence: Veye Chest
14 November 2019
X Ray, general
Model: 2.6 and higher
MHRA reference: 2019/011/019/291/017
Beckman Coulter: DxH Slidemaker Stainer & DxH Slidemaker
14 October 2019
IVDs, haematology
MHRA reference: 2019/010/021/601/003
Boston Scientific: HABIB™ EUS RFA
18 November 2019
Surgical, diathermy
Model: 6500 and 6700
MHRA reference: 2019/011/018/291/007
Boston Scientific: Various devices impacted, refer to Appendix A
28 October 2019
Vascular cannula and catheters
MHRA reference: 2019/010/029/291/001
CardinalHealth (Medtronic): ValleylabTM FT and FX Series Energy Platform, LS Single Channel Vessel Sealing Generator
November 2019
Surgical, diathermy
Model: VLFT10GEN, VLFX8GEN, VLLS10GEN
MHRA reference: 2019/011/021/291/005
Cepheid: Xpert HIV-1 Viral Load
11 November 2019
IVDs, viral microbiology
MHRA reference: 2019/011/020/701/016
DePuy Synthes: EIT Implants (Cervical, PLIF, TLIF)
31 October 2019
Spinal implants
MHRA reference: 2019/011/013/291/006
Elekta Nucletron B.V: Flexitron HDR – Flexitron Cobalt-60
November 2019
Radiotherapy
Model: 136149 – 136005
MHRA reference: 2019/011/018/701/001
Elekta: Monaco RTP System
November 2019
Radiotherapy planning and verification systems
MHRA reference: 2019/011/020/701/014
Flowonix: Prometra® Programmable Pump System
08 October 2019
Implants, active, infusion pumps
Model: Prometra (REF 91827) and Prometra II (REF 93827)
MHRA reference: 2019/011/015/291/001
GE Healthcare: CHA* Anesthesia and CHA* Critical Care
GEHC Ref 38004
Monitors, patient
MHRA reference: 2019/011/015/291/010
Halyard Health: HALYARD* CLOSED SUCTION SYSTEM FOR NEONATES
04 November 2019
Airway suction equipment
MHRA reference: 2019/011/015/291/004
impedimed: Product Code 292-DTE
08 November 2019
ECG
Model: Dual-tab electrodes
MHRA reference: 2019/011/013/291/008
Laboratoires Anios: UNISEPTA FOAM 2
07 November 2019
Disinfectants for medical devices
MHRA reference: 2019/011/011/487/009
Medtronic: MiniMed 640G Insulin Pump; MiniMed 670G Insulin Pump
November 2019
Infusion systems
Model: Pump models: MMT-1711, MMT-1712;
MMT-1780, MMT-1781; MMT-1782
Kit models: MMT-1751; MMT-1752;
MMT-1760, MMT-1761, MMT-1762
MHRA reference: 2019/011/021/291/008
Medtronic: Refill Kit, Catheter Access Port Kit
November 2019
Infusion & transfusion, administration sets
MHRA reference: 2019/011/019/291/016
Obelis (Galil Medical): Visual-ICE Cryoablation System
01 November 2019
Surgical, cryogenic
MHRA reference: 2019/011/007/487/012
Olympus: TJF-160R, TJF-140R, JF-140R, TJF-240, JF-240, JF-1T40, JF-TE3
November 2019
Endoscopes, flexible
Model: Duodenovideoscopes and duodenofibroscopes
MHRA reference: 2019/011/015/291/002
RaySearch Laboratorie: RayStation
18 November 2019
Radiotherapy planning and verification systems
Model: RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 4.9 (RayPlan 1), RayStation 5, RayStation 6 (RayPlan 2), RayStation/RayPlan 7, RayStation/RayPlan 8A, RayStation/RayPlan 8B and RayStation/RayPlan 9A
MHRA reference: 2019/011/020/291/004
Schiller: Tempus LS
21 November 2019
Defibrillators, non implantable
MHRA reference: 2019/011/021/701/019
Siemens: SOMATOM CT
September 2019
Computed tomography
Model: 8098027, 10267000, 10430603, 10431700, 10590000, 10590100, 10742326
MHRA reference: 2019/009/030/601/003
Thermo Fisher: Oxoid
14 November 2019
IVDs, bacteriology
Model: PB0226A.PB0820A.PB1205A.PB1241E
MHRA reference: 2019/011/014/601/009
Tytek Medical: PneumoDart
15 November 2019
Surgical instruments, minimal access
Model: TM 317
MHRA reference: 2019/011/021/701/002
USF Healthcare: UNISEPTA FOAM 2
08 November 2019
Disinfectants for medical devices
Model: 2458
MHRA reference: 2019/011/012/291/009
W.L. Gore & Associates: GORE® DrySeal Flex Introducer Sheath
18 November 2019
Vascular cannula/catheter accessories
Model: 14Fr, 33cm
MHRA reference: 2019/011/018/291/008