Field Safety Notices - 13 July to 17 July 2020
Summary list of field safety notices (FSNs) from medical device manufacturers from 13 July to 17 July 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
FSNs before this date are on the National Archives Website
AD-TECH
11 June 2019
Implants, active, leads, neuro
Model: Electrode, cortical; Electrode, depth; Anchor Bolt
MHRA reference: 2020/005/016/601/003
Becton Dickinson: BD MAX™ SARS-CoV-2 Reagents
10 July 2020
IVDs, SARS-CoV-2 PCR test
MHRA reference: 2020/007/010/291/005
Cook Medical: Dawson-Mueller Drainage Catheter
02 January 2020
Wound drains
MHRA reference: 2019/012/024/487/005
Hemoteq AG: Ranger™ and Ranger™ SL OTW Paclitaxel-Coated PTA B
92489879-FA
Vascular cannula and catheters
MHRA reference: 2020/007/010/291/003
Medtronic: GuardianTM Connect Application
July 2020 FA922
Software as a medical device (SaMD)
MHRA reference: 2020/007/015/487/017
Medtronic: HeartWare™ HVAD™ System
July 2020
Implantable ventricular assist devices
Model: Controller - 1400, 1401, 1403, 1407, 1420 DC Adapter - 1435, 1440 AC Adapter - 1425, 1430 Battery Pack – 1650
MHRA reference: 2018/005/008/228/001
Medtronic: SynchroMed II Clinician Programmer Application
July 2020 FA921
Implants, active, infusion pumps
Model: A810
MHRA reference: 2020/007/015/487/010
Olympus: Single Use Guide Sheath Kit
13 July 2020
Surgical instruments, minimal access
Model: K-401 & K-402
MHRA reference: 2020/007/013/487/008
Ossur hf: J-Tong
July 2020
Osteosynthesis, external fixators
Model: JT-100, JT-110, JT-115, JT-200, JT-210, JT-215, JT-400
MHRA reference: 2020/007/010/291/001
Össur: Thomas Splint
July 2020
Orthoses
Model: TS1, TS2, TSH1, TSH2, TSH3, TSH4, TSH5, TSH6, TSNPA, TSNPP, TSP1, TSP2, TSSP1, TSSP2
MHRA reference: 2020/007/010/291/002
Siemens Healthcare: Cios Alpha & Cios Spin
July 2020
X Ray, fluoroscopy systems
MHRA reference: 2020/007/014/601/002
TeDan Surgical Innovations: PHANTOM CS DISTRACTION SCREW, 14 MM, STERILE, 5/BOX
25 June 2020
Osteosynthesis, bone screws
Model: DS‐0014
MHRA reference: 2020/007/007/291/001