Field Safety Notice - 18 to 22 December 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 18 to 22 December 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
Abbott: ARCHITECT DHEAS-S Reagent Kit
14 December 2017
IVDs, clinical chemistry
Model: 8K27-20; 8K27-25
MHRA reference: 2017/012/019/071/002
Arkray Factory
08 December 2017
IVDs, self / home testing
Model: SPOTCHEM II
MHRA reference: 2017/012/018/291/006
BIOMERIEUX: ETEST®TP 256 (TEICOPLANIN)
15 December 2017
IVDs, bacteriology
MHRA reference: 2017/012/021/291/001
Biomet Orthopedics
18 December 2017
Bone cement and tools
Model: OPTIPAC 40 REFOBACIN
MHRA reference: 2017/012/019/071/001
Boston Scientific: VALITUDE™, VISIONIST™ CRT-P and CHARISMA™, MOMENTUM™, RESONATE™, VIGILANT™, AUTOGEN™, DYNAGEN™, INOGEN™, ORIGEN™ CRT-D
December 2017
Implants, active, pacemakers
MHRA reference: 2017/012/019/291/018
Boston Scientific: ACCOLADE, ALTRUA 2, ESSENTIO, PROPONENT, VALITUDE, VISIONIST
December 2017
Implants, active, pacemakers
MHRA reference: 2017/012/019/291/016
Boston Scientific Corporation: Uro / Pelvic Health:
Malecot Nephrostomy Catheter Set Re-Entry™ Malecot Nephrostomy Catheter Set Percutaneous Access Set Peripheral Intervention: Malecot Nephrostomy Catheter System
14 December 2017
Urinary catheters and accessories
Model: Uro/Pelvic Health:
Malecot Nephrostomy Catheter Set M0064101000 M0064101010
Re-Entry Malecot Nephrostomy Catheter Set M0064101040 M0064101050
Percutaneous Access Set M0064201150
Peripheral Intervention Malecot Nephrostomy Catheter System M001224110
MHRA reference:2017/012/018/291/017
CareFusion: Vyntus BODY with Option Diffusion
30 November 2017
Therapy tissue ablation
MHRA reference: 2017/012/019/228/007
Cepheid: Xpert® GBS
07 December 2017
IVDs, bacteriology
MHRA reference: 2017/012/020/291/028
Cepheid: 17FAR013 HIV-1 VL Cepheid FSCA ANSM Ref R1720294
6 December 2017
IVDs, viral microbiology
MHRA reference: 2017/012/018/131/001
Cook Medical: Norm-Ject Tuberkulin Syringe
19 December 2017
Laboratory equipment associated with IVF, cells, tissues
Model: Norm-Ject Tuberkulin Syringe
MHRA reference: 2017/012/020/291/002
Cousin Biotech: NAJA
20 December 2017
Spinal implants
Model: RCBNAJ55LU, RCBNAJ55RU
MHRA reference: 2017/012/020/291/033
Covidien
12 December 2017
Lung ventilators
Model: Puritan Bennett 980 Ventilator & PB980 Rechargeable Lithium Ion Battery
MHRA reference: 2017/012/018/228/020
Covidien (Medtronic): Signia Power Handle
December 2017
Staples and staple guns
MHRA reference: 2017/012/020/291/029
DePuy Spine: Confidence Spinal Cement System
December 2017
Bone cement and tools
Model: 283910000; 283913000
MHRA reference: 2017/012/019/291/019
Depuy Synthes: GLOBAL® UNITE® Platform Shoulder System
December 2017 Joint prosthesis, shoulder
MHRA reference: 2017/012/018/701/021
Establishment Labs: Motiva Implants
18 December 2017
Implants, breast
Model: ERSF-255Q
MHRA reference: 2017/007/029/601/001
Greiner Bio-One: VACUETTE FC MIX Tube
20 December 2017
IVDs, specimen receptacles
Model: 454510, 454511, 454513, 454514
MHRA reference: 2017/012/020/228/003
Konica Minolta
13 December 2017
Ultrasound, imaging
Model: Sonimage HS1
MHRA reference: 2017/012/019/228/005
MAKO Surgical Corp: MCK TIBIAL BASEPLATE-RM/LL-SZ 2 & 7
December 2017
Joint prosthesis, knee
MHRA reference: 2017/012/020/291/001
Medtronic Sofamor Danek: KYPHON® Express Directional Bone Filler
December 2017
Bone cement and tools
Model: F06B
MHRA reference: 2017/012/019/228/004
Monica Healthcare (GE): Monica Novii Wireless Patch System, Monica IF24
December 2017
Monitors, foetal
MHRA reference: 2017/012/019/131/001
Nobel Biocare: IPS CaseDesigner
07 December 2017
X ray, dental imaging
MHRA reference: 2017/012/013/228/022
Physio-Control
December 2017
Defibrillators, non implantable
Model: 3202380-006
MHRA reference: 2017/012/014/228/011
Roche: Elecsys BRAHMS PCT
14 December 2017
IVDs, clinical chemistry
MHRA reference: 2017/012/019/291/014
Siemens Healthcare Diagnostic Products Limited: Various analytes
13 December 2017
IVDs, clinical chemistry
MHRA reference: 2017/012/015/601/010
Siemens: ADVIA Centaur
December 2017
IVDs, clinical chemistry
Model: ADVIA Centaur CP, ADVIA Centaur XP, ADVIA Centaur XPT
MHRA reference: 2017/012/021/601/003
Smith & Nephew Orthopaedics: Taylor Spatial Frame Website Software
13 December 2017
Osteosynthesis, external fixators
MHRA reference: 2017/012/019/071/003
Spectranetics: 0.9 mm X-80 VITESSE RX CATHETER
14 December 2017
Vascular cannula and catheters
Model: 110-004
MHRA reference: 2016/012/014/701/005
TRUMPF: TruVidia™ Wireless Receiver
December 2017
Lamps & lights
MHRA reference: 2017/012/018/228/024
WallacOy: LifeCycle for Prenatal Screening
14 December 2017
IVD, genetic testing
Model: 5015-0020
MHRA reference: 2017/012/020/228/004
Zimmer: Various Hip and Knee products
15 December 2017
Joint prosthesis, knee
MHRA reference: 2017/012/019/131/002
Zimmer Biomet: Persona Partial Knee Spacer Blocks
12 December 2017
Joint prosthesis, knee
Model: Persona Partial Knee Spacer Blocks
MHRA reference: 2017/012/018/701/036
Zimmer GmbH: MODULAR RASP DISTAL CURVED REVITAN RASP DISTAL CUR
15 December 2017
Joint prosthesis, hip
MHRA reference: 2017/012/019/131/003