Field Safety Notice: 07 to 21 June 2019
List of field safety notices (FSNs) from medical device manufacturers from 07 to 21 June 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
Alere: Alere
24 June 2019
IVDs, clinical chemistry DDS2-403, DDS2-404
MHRA reference:
Biomet: DVR Express Disposable Instruments
18 June 2019
Orthopaedic surgical instruments - insertion/extraction tools
MHRA reference:
Diamed 鈥� Bio-Rad: DiaClon Rh-Subgroups + K
11 June 2019
IVDs, blood transfusion Model: 50110//50115
MHRA reference:
Elekta:Elekta Unity
June 2019
Radiotherapy
MHRA reference:
Intersurgical: 15mm Flextube Single Heated Wire Breathing Systems
19 June 2019
Humidifiers
MHRA reference:
Johnson & Johnson: Neutrogena Light Therpay Acne Mask and Refill
19 June 2019
Therapy, adult phototherapy
MHRA reference:
Maquet - Getinge: Cardiosave, CS100,CS300 Intra-Aortic Balloon Pumps
2249723-05/17/2019-001-C鈥擥B Cardiac assist pumps
MHRA reference:
MEDICAL INNOVATION: MID-TUBE
14 June 2019
Feeding systems and tubes
Model: MID136
MHRA reference:
Medtronic: Sherpa Active 6F Guide Catheter
June 2019
Vascular cannula and catheters Model: SA6IMAK, SA6RDND1K, SA6RBU35, SA6HSI, SA63DRCSH, SA6AR10, SA6AR20, SA6LCBD, SA63DRC, SA6RBU35SH, SA6AR10SH, SA6RDCK, SA6JL40D, SA6FL40, SA6AR20SH, SA6IMAD, SA6MPHK, SA6HSISH, SA6FL40SH, SA6JR40D, SA6AL10A, SA6AL20A, SA6EBU35A, SA6NOTOSH, SA6SR30, SA6JL40A, SA6IMA, SA6IMASH, SA6PK1W, SA6JR40K, SA6CHAMP05, SA6EBU40A, SA6RCBSHD, SA6RCBD, SA6LCBSHD, SA6CHAMP20K, SA6EBU35D, SA6JCR40, SA6NOTO, SA6AL10D, SA6SR40SH, SA6SR40, SA6CHAMP05SH, SA6AL30A, SA6MP1K, SA6JL50A, SA6JR40A, SA6JL35A, SA6AL75A, SA6MB1D, SA6IMASHJ MHRA reference:
Mercian Surgical Supply:900G MALLET
19 June 2019
Surgical devices, non-powered
Model: Mallet with Black PEEK Handle 21.5cm 40mm Diameter 900g - HA5806-21
MHRA reference:
Natus Medical: Chartr EP 200
May 2019
Stimulators diagnostic
MHRA reference:
RMS: MARLEY/RMS
01 June 2019
Buggies for disabled people
Model: MRL-1 and MRL-2
MHRA reference:
Siemens: ARTIS zee and ARTIS Q
27 May 2019
X Ray, fluoroscopy systems
MHRA reference:
Thermo Fisher: Oxoid
14 June 2019
IVDs, bacteriology PO0152A
MHRA reference:
Zoll: ZOLL AED PRO
12 June 2019
Defibrillators, non-implantable
MHRA reference: