Field Safety Notice: 27 to 31 May 2019
List of field safety notices (FSNs) from medical device manufacturers from 27 to 31 May 2019
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
Abbott: Alinity i BNP Calibrators, Alinity i BNP Controls
24 May 2019
IVDs, clinical chemistry
MHRA reference:
Abbott: Alinity ci-series System Control Module
21 May 2019
IVDs, clinical chemistry
MHRA reference:
Abbott: ARCHITECT BNP Calibrator kit, ARCHITECT BNP Control kit
24 May 2019
IVDs, clinical chemistry
MHRA reference:
Arjo: System 2000 including Rhapsody, Primo, PrimoFerro
FSN-POZ-001-2019 Bath and aids AP01300GB1010, AP31200GB0010, AP31300GB1010, AP31301GB1010, AP31800GB1000, AR01211GB1010, AR01800GB1000, AR31300GB1010, AR31800GB1000, AR31800GB1010, AR32201GB1110, AR32811GB1000, AS31801GB0000, AS31811GB0010, AR01300GB1010, AR32301GB1110, AP31301GB1010, AP31300GB1010, AR31300GB1010, AR31800GB1000, AP32211GB1000, AR31200GB1010
MHRA reference:
Becton Dickinson: BD Microtainer庐 Tubes
06 June 2019 IVDs, Specimen Receptacles
MHRA reference:
Medtronic: Endo GIATM Surgical Stapling Single Use Loading Units, Tri-StapleTM 2.0 Intelligent Reloads and Cartridges
May 2019
Staples and Staple Guns EGIA30AMT, EGIA45CTAMT, EGIA60AXT, EGIA60CTAMT, SIG30AMT, SIG45AXT, SIG45CTAMT, SIG60AXT, SIG60CTAMT, EGIA45AMT, EGIA60AMT
MHRA reference:
EKOS Corp: EKOS Control System 4.0
20 May 2019
Ultrasound, imaging
MHRA reference:
GE: Centricity Universal Viewer
FMI 85449 Endoscopes, televisual systems
MHRA reference:
Leonhard Lang: Mindray- Weinmann defibrillation electrodes
15 May 2019
Defibrillators, non-implantable 50607 MDF1A_MIND DF81C MINDRAY ADULT 0-1-10-60
MHRA reference:
LivaNova: VNS Therapy庐 SenTiva庐 Generator
28 May 2019
Implants, active, stimulators, neuro Model 1000
MHRA reference:
Randox Laboratories: HUMAN ASSAYED MULTI-SERA Level 2
23 May 2019
IVDs, clinical chemistry HN1530
MHRA reference:
Richard Wolf: CUTTING ELECTRODE MONO 11.5FR 0
27 May 2019
Surgical instruments, minimal access 8416.03
MHRA reference:
Roche Diagnostics: IGA-2 (Tina-quant IgA Gen.2)
CN-431825 IVDs, immunology
MHRA reference:
Roche: Elecsys Syphilis (200 test/kit)
May 2019
IVDs, bacteriology
MHRA reference:
Siemens: ARTIS zee and AXIOM Artis
13 May 2019
X Ray, fluoroscopy systems
MHRA reference:
Stryker: 2.7 Degree Straight Sagittal Saw and 2.7 Degree Angled Sagittal Saw
09 May 2019
Surgical power tools
MHRA reference:
TEC COM GmbH: TECOtherm NEO
28 May 2019
Blood/fluid warming systems
MHRA reference:
Teleflex: Sheridan
27 May 2019
Airway devices
MHRA reference: