Field safety notices - 21 to 25 December 2015
List of field safety notices (FSNs) from medical device manufacturers from 21 to 25 December 2015
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.
See more information on what an FSN is and why it’s important.
Latest FSNs
Acist Medical: BT2000 Manifold Kit, CPT2000 Manifold Kit
21 December 2015
Media Injectors
Model: BT2000, CPT2000
MHRA reference: 2015/012/022/291/025
alamedics: ala®purple
21 December 2015
Implants, Non active, Intraocular
Model: ala®purple
MHRA reference: 2015/012/021/701/018
Ambu A/S: 408 300 000
9 December 2015
Laryngeal mask airway
Model: Ambu® AuraGain™ Size #3
MHRA reference: 2015/012/010/181/002
Bayer Medical Care: MEDRAD IntegoTM PET Source Administration Sets
8 December 2015
Infusion & transfusion, administration sets
MHRA reference: 2015/012/010/292/018
Becton Dickinson: FMC7 FITC
17 December 2015
IVDs, cytopathology & histopathology
Model: 332786
MHRA reference: 2015/012/023/601/001
Brainlab: iPlan RT Image (below v.4.1.2)
7 September 2015
Radiotherapy planning and verification systems
Model: BrainSCAN (end-of-life)
MHRA reference: 2015/010/006/292/019
Brainlab
05 November 2015
Radiotherapy planning and verification systems
Model: Brain Metastases, Adaptive Hybrid Surgery Analysis
MHRA reference: 2015/011/020/292/016
Cardiac Science
December 2015
Defibrillators, Non implantable
Model: PN 9131-001
MHRA reference: 2015/012/021/292/015
Coloplast A/S: Vortek - Single Loop Ureteral Stent
22 December 2015
Implants, Non active, Non vascular stents
MHRA reference: 2015/012/022/701/038
Cook Ireland Ltd: Zilver® 518RX Vascular Stent
17 December 2015
Implants, Non active, peripheral vascular stents
Model: see FSN
MHRA reference: 2015/012/024/701/001
Depuy Synthes: Spine Cable System
18 December 2015
Surgical Instruments, Implant
Model: Spine Cable System; 321.131
MHRA reference: 2015/012/021/291/020
Fukuda Densh: DYNASCOPE
11 December 2015
Monitors, Patient
Model: DS 8100
MHRA reference: 2015/012/018/601/006
Maquet: Cardiosave Hybrid/Rescue IABP
17 December 2015
Cardiac assist pumps
Model: 0998-00-0800-XX & 0998-UC-0800-XX
MHRA reference: 2015/012/022/292/006
Radiometer: AQURE system
FAN 915-345
IVDs, extra laboratory testing
Model: Flexlink (933-504)
MHRA reference: 2015/012/022/291/001
Siemens Healthcare: INNOVANCE PFA P2Y
December 2015
Coagulation
MHRA reference: 2015/012/023/292/010
Stryker Trauma GmbH: sterile pack. Guide wires, K-Wires , Metaizeau pin
22 December 2015
Osteosynthesis, skeletal pins, wires & staples
Model: sterile pack. Guide wires, K-Wires, Metaizeau pin
MHRA reference: 2015/012/022/291/026
Vygon: NS2 6FR DEHP Free PVC tube 75CM XRO
22 December 2015
Feeding systems and tubes
Model: 0363062
MHRA reference: 2015/012/022/601/007
Zimmer: NexGen Precoat/Option Stemmed Tibia
18 December 2015
Joint prosthesis, knee
Model: NexGen Precoat/Option Stemmed Tibia
MHRA reference: 2015/012/021/291/006
Zimmer: Zimmer Universal Locking System
21 December 2015
Osteosynthesis, bone plates
MHRA reference: 2015/012/021/292/023