Field Safety Notice - 26 to 30 June 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 26 to 30 June 2017
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
AlterG: Anti-Gravity
26 June 2017
Therapy, standing & walking
Model: M320
MHRA reference: 2017/006/027/291/023
Bio-Rad Laboratories: ID-DiaCell's
03 May 2017
IVDs, blood transfusion
MHRA reference: 2017/002/013/291/011
Biomet: ExploR 6x24mm Implantable Stem with Screw
28 June 2017
Joint prosthesis, elbow
MHRA reference: 2017/006/029/291/015
Boston Scientific Corporation: Encore™ 26 Inflation Device
20 June 2017
Vascular cannula/catheter accessories
Model: H74904526011, M001151050, M00566670,
M0067101140
MHRA reference: 2017/006/019/291/015
CellaVision: DI-60
16 June 2017
IVDs, haematology
MHRA reference: 2017/006/028/291/003
Cook: Vue Optic Visualization Source Flexor Vue Deflecting Endoscopic System
07 June 2017
Endoscopes, televisual systems
MHRA reference: 2017/006/013/291/017
Cook Medical: Zenith Alpha™ Thoracic Endovascular Graft
June 2017
Implants, non active, endoprostheses for aortic aneurysms
Model: Zenith Alpha™ Thoracic Endovascular Graft
MHRA reference: 2017/006/026/291/014
DePuy Synthes
21June 2017
Osteosynthesis, bone screws
Model: 04.511.635.04S, 04.511.666.04S, 04.511.226.04S
MHRA reference: 2017/006/023/291/014
GE Healthcare: Centricity™ High Acuity Critical Care
FMI 85440
Monitors, patient
MHRA reference: 2017/006/026/291/008
HOYA: PENTAX ULTRASOUND UPPER GI VIDEOSCOPES
26 June 2017
Endoscopes, flexible
Model: EG-3870UTK and EG-3670URK
MHRA reference: 2017/006/019/291/035
Helena BioSciences: APTT Si L Minus, APTT (SILICA) 5558SLQ, 5559SLQ, 5560SLQ, 5562SLQ, OQLS493502, OQLS955502
23 June 2017
Coagulation
MHRA reference: 2017/006/023/601/006
Hitachi High Technologies Corporation
21 June 2017
IVDs, clinical chemistry
Model: cobas e 411 (disk system), Model No. 04775279001
cobas e 411 (rack system), Model No. 04775201001
Elecsys 2010 analyzer (disk system), Model No. 11568248001
Elecsys 2010 analyzer (rack system), Model No. 11804014001
cobas e 411 (disk system), Model No. 04775279001
cobas e 411 (rack system), Model No. 04775201001
Elecsys 2010 analyzer (disk system), Model No. 11568248001
Elecsys 2010 analyzer (rack system), Model No. 11804014001
MHRA reference: 2017/006/023/701/006
Hologic: Tomcat Instrument
4475396
IVDs, cytopathology & histopathology
MHRA reference: 2017/006/026/601/009
Joerns Healthcare: Oxford Dipper
000017
Hoists and slings
MHRA reference: 2017/003/029/299/020
Medtronic: 11001G - DLP® Extension Line Adapters 20 in length; 13001 - DLP® Antegrade/Retrograde Adapter;
15004 - DLP® Cardioplegia Adapter with Pressure Port; 25009 - DLP® Pressure Monitoring Extension Line Adapters; 25010 - DLP® Pressure Monitoring Extension Line Adapters; 61000 - DLP® Pressure Disposable Pressure Display Sets; 62000 - DLP® Pressure Disposable Pressure Display Sets
23 June 2017
Infusion & transfusion, heart lung circuits
MHRA reference: 2017/006/026/291/010
NBS Reagents: Titration cells cell 1
22 June 2017
IVDs, blood transfusion
Model: R407 5188
MHRA reference: 2017/006/023/601/007
Orthofix: POWER DRILL TORQUE LIMITER
28 June 2017
Osteosynthesis, external fixators
Model: 99-93568
MHRA reference: 2017/006/029/291/003
Prism: Freeway Easyfit System
28 June 2017
Hoists and slings
Model: 1102PHATPEF
MHRA reference: 2017/006/027/601/007
QIAGEN: QIAamp DSP Virus Kit
22 June 2017
IVDs, viral microbiology
Model: QIAamp DSP Virus Kit
MHRA reference: 2017/006/023/701/008
Thermofisher Scientific: ThermoScientific Oxoid GC Agar
29 June 2017
IVDs, bacteriology
Model: CM0367
MHRA reference: 2017/006/029/601/006