Field safety notices - 25 to 29 June 2018
Summary List of field safety notices (FSNs) from medical device manufacturers from 25 to 29 June 2018.
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
Baxter: SUPOR Syringe Filter, 0.2 Micron, 25mm
May 2018
Infusion & transfusion, administration sets
Model: 112062
MHRA reference: 2018/006/025/081/023
Intuitive Surgical: da Vinci® Xi™ EndoWrist Suction Irrigator
ISIFA2018-09-C
Endoscopes, rigid
Model: 480299-04
MHRA reference: 2018/006/015/701/010
Magellan Diagnostics: LeadcareII/Leadcare Plus
18 June 2018
IVDs, clinical chemistry
MHRA reference: 2018/006/026/081/006
Medtronic: Percepta™ CRT-P MRI SureScan™ and Percepta™ Quad CRT-P MRI SureScan™ Pacemakers
June 2018
Implants, active, pacemakers
Model: W1TR04, W4TR04
MHRA reference: 2018/006/028/081/012
Medtronic - ICD: EnTrust® and Escudo® VR/DR/AT ICDs
June 2018
Implants, active, defibrillators
MHRA reference: 2018/006/028/081/013
Microgenics (ThermoFisher): QMS Teicoplanin Calibrator
18 June 2018
IVDs, clinical chemistry
MHRA reference: 2018/006/019/701/012
Olympus: VISERA ELITE II VIDEO SYSTEM CENTER OLYMPUS
22 June 2018
Endoscopes, televisual systems
Model: OTV-S200 & OTV-S300
MHRA reference: 2018/006/021/291/001
Ortho Solutions: FPS 2.7/3.5MM Depth Gauge
18 June 2018
Orthopaedic surgical instruments
Model: OS328001
MHRA reference: 2018/006/021/601/008
Radiometer: ABL800 (Update)
June 2018
IVDs, extra laboratory testing
Model: 393-800, 393-801
MHRA reference: 2018/006/020/291/002
Radiometer Medical: ABL800 Analyzer
June 2018
IVDs, extra laboratory testing
Model: ABL800 Analyzer 393-801
MHRA reference: 2018/006/025/701/020
Samsung: FSN - GC80,GC85,GC70
FSN- GC_180530-1
X Ray, digital acquisition systems
MHRA reference: 2018/005/031/701/013
Siemens Healthcare: Artis Q/Pheno systems
20 June 2018
X Ray, fluoroscopy systems
Model: Artis Q/Pheno systems and X-ray generator A100
MHRA reference: 2018/006/022/601/005
Stryker: LFIT Anatomic CoCr V40 Femoral Heads
May 2018
Joint prosthesis, hip
MHRA reference: 2018/005/025/291/022
Zimmer Biomet: Guide Wire
21 June 2018
Surgical instruments, minimal access
Model: Guide Wire
MHRA reference: 2018/006/021/701/023