Field Safety Notice - 20 to 24 November 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 20 to 24 November 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
Accuray Incorporated: TomoTherapy Treatment System
08 November 2017
Radiotherapy
Model: TomoTherapy H Series, TomoTherapy Hi-Art
MHRA reference: 2017/011/023/701/011
Alba Bioscience: ALBAClone Anti-Leb
22 November 2017
IVDs, blood transfusion
Model: Z217
MHRA reference: 2017/011/022/601/014
B Braun: Perfusor Compact Plus
17 November 2017
Infusion systems
Model: Perfusor compact plus; 8717030
MHRA reference: 2017/011/017/601/005
CellaVision: 1. DI-60, 2. CellaVision DM96, 3. CellaVision DM1200, 4. CellaVision DM9600
07 November 2017
IVDs, haematology
Model: N/A
MHRA reference: 2017/011/017/291/030
CEPHEID: MRSA
20 October 2017
IVDs, bacteriology
Model: N/A
MHRA reference: 2017/011/006/701/011
HTL-Strefa S.A
13 November 2017
Insulin injection devices
Model: Microdot droplet pen needle 4mm x 32G 810
MHRA reference: 2017/010/023/291/010
Iris Diagnostics (a Division of Iris International Inc.): iQ200 Series Urine Microscopy Analyzer
21 November 2017
IVDs, clinical chemistry
Model: N/A
MHRA reference:2017/011/022/601/016
Life Technologies Corporation: Fetal Hemoglobin Monoclonal Antibody (HBF-1)
20 November 2017
IVDs, blood transfusion
Model: MHFH04, MHFH014, MHFH01
MHRA reference:2017/011/016/601/010
MEDICREA INTERNATIONAL: PASS OCT/ occipital screw driver shaft
20 November 2017
Orthopaedic Surgical instruments - Insertion/extraction tools
Model: A17260020
MHRA reference: 2017/011/022/291/015
Phadia AB: Phadia AB PRIME
QA2017-08
IVDs, immunology
Model: N/A
MHRA reference: 2017/011/022/601/008
Remel Europe Ltd - Thermofisher Scientific: Thermo Scientific™ Remel™ Shigella sonnei (Phases 1&2) Agglutinating Serum
20 November 2017
IVDs, bacteriology
Model: R30164201
MHRA reference: 2017/011/022/601/013
St. Jude Medical (Abbott): Nanostim™ Leadless Pacemaker
17 November 2017
Implants, active, pacemakers
Model: Nanostim™ Leadless Pacemaker S1DLCP
MHRA reference: 2017/011/017/291/010
Teleflex: RUSCH Sensor (Series 400) Silicone
Rectal Pharyngeal Temperature Sensor, Non-Sterile
23 November 2017
Urinary catheters and accessories
MHRA reference: 2017/011/024/228/008
United Orthopedic: U2 Total Knee System Tibial Insert, PS & PSA
17 November 2017
Joint prosthesis, knee
Model: 2303-3032 & 2303-5016
MHRA reference: 2017/011/022/291/012
Vascutek: Anaconda™ Longer Leg Iliac Stent Graft System
30 October 2017
Implants, non active, endoprostheses for aortic aneurysms
Model: N/A
MHRA reference: 2017/011/013/291/001
Volcano (Philips): 400-0100.01
21 November 2017
Ultrasound, imaging
Model
MHRA reference:2017/011/022/291/017
WallacOy: Specimen Gate Screening Center
16 November 2017
IVD, genetic testing
Model: 5002-0500
MHRA reference: 2017/011/017/291/007
Wassenburg: WASSENBURG WD440, WD440 PT, WD415
15 November 2017
Cssd wash/clean/drying equipment
Model: N/A
MHRA reference: 2017/011/020/701/004
Zimmer
13 August 2017
Dental appliances / instruments
Model: 2220, 2222, 2223, 2224, HLA3G, HLA4G, HLA5G, NEA3G, NEA4G, ZOAT34, ZOAT45, ZOAT56, ZOATKIT, ZOCIMP3A, ZOCIMP3S, ZOCIMP4A, ZOCIMP4S, ZOCIMP5A, ZOCIMP5S, ZOCIMP6A, ZOCIMP6S, ZOCWAX3A, ZOCWAX3S, ZOCWAX4A, ZOCWAX4S, ZOCWAX5A, ZOCWAX5S, ZOCWAX6S, ZOP30A10, ZOP30A11, ZOP30A13, ZOP30S10, ZOP30S11, ZOP30S13
MHRA reference: 2017/011/017/701/025
Zimmer Biomet: TunneLoc Tibial Fixation
17 November 2017
Ligaments, tendons and anchors
Model: N/A
MHRA reference: 2017/011/017/291/018