Field Safety Notice - 9 to 13 October 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 9 to 13 October 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:Alinity hq Analyzer
5 October 2017
IVDs, haematology
MHRA reference: 2017/010/012/291/010
Agilent: FLEX Monoclonal Rabbit Anti-Human Estrogen Recepto
5 October 2017
IVDs, cytopathology & histopathology
MHRA reference: 2017/010/009/701/030
Alba Bioscience: ALBAcyte
09 October 2017
IVDs, blood transfusion
Model: ALBAcyte Reagent Red Cells for Antibody Identification (Papainised)
MHRA reference: 2017/010/009/601/001
Beckman Coulter: AQUIOS CL Flow Cytometer System
09 October 2017
IVDs, haematology
MHRA reference: 2017/010/009/601/003
Biomet: Vanguard CR Tibial Bearing
09 October 2017
Joint prosthesis, knee
MHRA reference: 2017/010/010/701/022
CareFusion: Alaris™/ Asena™ GS, GH, CC, TIVA, PK, Syringe Pumps
September 2017
Infusion systems
Model: all variants with prefix 8001, 8002, 8003, 8004, and 8005 (pumps manufactured before September 2008 only)
MHRA reference: 2017/010/003/701/009
Endologix: Nellix, Endovascular Aneurysm Sealing System
06 October 2017
Implants, non active, endoprostheses for aortic aneurysms
Model: N10-100, N10-110, N10-120, N10-130, N10-140, N10-150,N10-160, N10-170, N10-180, N10-190, N10-200, NP-002; NP-001; NP-003; NP-005; NX-001, NX-002a
MHRA reference: 2017/010/006/601/002
LINET: Multicare
18 August 2017
Beds and accessories
Model: Multicare 1MC
MHRA reference: 2017/010/009/291/024
Medacta International SA
29 September 2017
Joint prosthesis, knee
Model: GMK Sphere & GMK Primary PS Inserts – all codes
MHRA reference: 2017/010/005/701/007
Medtronic: CareLinkTM iProTM Therapy Management Software (component of iPro Continuous Glucose Monitoring System)
October 2017
Continuous glucose monitoring systems (CGMS)
Model: MMT-7340
MHRA reference: 2017/010/012/291/053
Medtronic:FlexCath Advance™ Steerable Sheath
October 2017
Vascular cannula/catheter accessories
Model: 4FC12
MHRA reference: 2017/010/012/291/041
NordicNeuroLab: AudioSystem-Headphone Slim
28 September 2017
Stimulators diagnostic
MHRA reference: 2017/010/005/291/018
Otto Bock: Voyager Evo rigid frame wheelchair
4 October 2017
Wheelchairs, manual
Model: 480A76=00000_K
MHRA reference: 2017/010/012/291/040 ### Philips
September 2017
Monitors, patient
Model: Cisco ASA 5506-X Network Firewall. 867098
MHRA reference: 2017/010/009/291/022
Radiometer: TCM5 FLEX/TCM5 BASIC
FAN 915-375
Diagnostic measurement and monitoring
MHRA reference: 2017/010/012/291/008
Randox Laboratories: Liquid Cardiac Control
17 February 2017
IVDs, clinical chemistry
Model: CQ5051, CQ5052 & CQ5053
MHRA reference: 2016/009/016/601/009
Schaerer Medical AG: schaerer arcus
26 September 2017
Operating table
MHRA reference: 2017/004/003/299/001
Stryker: Various Stryker Hip Products
26 September 2017
Joint prosthesis, hip
MHRA reference: 2017/010/011/291/016
Stryker: TACTYS - IPP prosthesis - Distal Stem Size S and M
October 2017
Joint prosthesis, hip
MHRA reference: 2017/010/006/701/013
Teleflex: AUTO ENDO05 ML
12 October 2017
Clip appliers
MHRA reference: 2017/010/012/291/044
Tracoe medical: TRACOE twist
11 October 2017
Airway devices
Model: REF 301-06, REF 302-06, REF 303-06, REF 304-06, REF 306-06
MHRA reference: 2017/010/012/291/043
Trans Medics: OCS Heart
2 October 2017
Storage & collection devices
Model: OCS Heart; 1200
MHRA reference: 2017/010/002/601/007
Vascutek: Anaconda™ ONE-LOK™ AAA Stent Graft System
28 September 2017
Implants, non active, endoprostheses for aortic aneurysms
MHRA reference: 2017/009/027/701/023
Zimmer: Pulsavac Plus
27 September 2017
Surgical equipment, miscellaneous
MHRA reference: 2017/010/010/701/005
Rochester Medical
FA2017-51
Urinary catheters and accessories
Model: HYDROSIL Gripper, Personal and Magic3 Intermittent; NA
MHRA reference: 2017/010/006/701/009
Last updated 24 October 2017 + show all updates
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