Field safety notices - 28 May to 1 June 2018
Summary List of field safety notices (FSNs) from medical device manufacturers from 28 May to 1 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
Abbott (Thoratec Corporation): HeartMate 3™ Left Ventricular Assist System – Updated FSN
25 May 2018
Implantable ventricular assist devices
Model: 106524INT HM3 LVAS Kit
MHRA reference: 2018/004/009/291/032
Arrow International (Teleflex Medical): VPS Rhythm™ ECG Accessory Pack with Johans Adapter
VPS Rhythm™ ECG Accessory Pack VPS TipTracker™ Stylet Accessory Peripherally Inserted Midline Catheter Kit with Placement Wire
24 May 2018
Vascular cannula and catheters
MHRA reference: 2018/005/025/478/011
Berlin Heart: Ventricular
28 May 2018
Implantable ventricular assist devices
Model: P10P-001, P15P-001, P25P-001x01, P30P-001x01, P50P-001, P60P-001
MHRA reference: 2018/005/028/601/002
DiaSys: Tests based on NAD(H) and/or NADP(H) reaction
28 May 2018
IVDs, clinical chemistry
MHRA reference: 2018/005/030/701/012
Draeger: Fabius, Apollo, Perseus A500
May 2018
Anaesthetic machines & monitors
MHRA reference: 2018/005/021/478/002
Heraeus: PALACOS® and COPAL® bone cements Brand
19 July 2017
Bone cement and tools
MHRA reference: 2018/005/030/291/009
Implant Direct: RePlant Angled Abutment 6050-52-60
May 2018
Implants, dental
MHRA reference: 2018/005/016/601/006
INEX SILICONE (SEBBIN): INEX SILICONE Devices
09 February 2018
Surgical instruments, minimal access
Model: Medical devices for lipofilling
MHRA reference: 2018/005/031/291/009
MAKO Surgical(Stryker): RIO system Irrigation Clip
May 2018
Surgical equipment, miscellaneous
MHRA reference: 2018/005/025/291/019
Megadyne: MegaPower Electrosurgical Generator
May 2018
Surgical, diathermy
MHRA reference: 2018/005/030/701/005
Microport CRM (former Livanova): PLATINIUM VR – Updated Cover Letter
15 May 2018
Implants, active, defibrillators
Model: VR 1240, DR 1540, CRT-D 1741, SonR CRT-D 1841, 4LV CRT-D 1744, 4LV SonR CRT-D 1844
MHRA reference: 2018/003/019/291/005
Millipore Ltd
May 2018
IVDs, clinical chemistry
Model: Minicon B-15, Minicon CS-15
MHRA reference: 2018/005/030/478/017
Newdeal SAS (INTEGRA): ADVANSYS MLP/DLP; ADVANSYS TTC; TIBIAXYS; UNI-CP;
17 May 2018
Osteosynthesis, bone screws
Model: 330021S; 330023S; 330025S; 30030S; 330217S; 330220S;
MHRA reference: 2018/005/025/291/009
Nursing Hygiene Group: Steiss
27 September 2016
Hoists and slings
Model: Hoist Activate 18
MHRA reference: 2017/011/029/601/006
Roche: IGG-2 (Tina-quant IgG Gen.2)
May 2018
IVDs, clinical chemistry
MHRA reference: 2018/005/030/701/029
Siemens: Biograph mCT and Biograph mCT Flow
MI516/16/S + MI513/17/S
Nuclear medicine, gamma camera systems & accessories
Model: 10248668, 10248669, 10248670, 10248671, 10248672
MHRA reference: 2018/005/030/601/005
Stanmore Implants: General Impactor
23 May 2018
Orthopaedic surgical instruments - impacting tools
Model: General Impactor imgenimp
MHRA reference: 2018/005/024/478/015
Wassenburg Medical: WASSENBURG endoscope
07 May 2018
Cssd wash/clean/drying equipment
Model: WD440, WD440 PT, WD415
MHRA reference: 2018/005/009/228/001
Last updated 13 July 2018 + show all updates
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Updated Document
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Updated Document
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First published.