Field Safety Notices - 22 - 26 May 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 22 - 26 May 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
Applied Medical: Kii Shielded Bladed Z-Thread Dual Pack
18 May 2017
Surgical instruments, minimal access
Model: CTB14, CTB23
MHRA reference: 2017/005/022/291/006
B&D Electromedical: NIPPY 3+ RANGE OF VENTILATORS
11 May 2017
Lung ventilators
MHRA reference: 2017/005/023/291/017
CareFusion: Brand
February 2017
Infusion systems
Model: 8000 and 8015
MHRA reference: 2017/005/025/291/035
Christoph Miethke: Shuntassistant
27 April 2017
Implants, non active, hydrocephalus
Model: FV253T
MHRA reference: 2017/005/019/291/011
Cook: See Comments Section
27 April 2017
Surgical devices, non-powered
MHRA reference: 2017/005/019/701/006
Dale Medical Products: 270/273 Endotracheal Tube Holders
25 April 2017
Airway devices
Model: H84102701 and H84102731
MHRA reference: 2017/005/015/291/003
DePuy Orthopaedics: PINNACLE® Hip Sector DUOFIX® HA Shell 58MM
Feb 2017
Joint prosthesis, hip
MHRA reference: 2017/005/023/299/001
GE OEC Medical Systems: OEC Elite
FMI 15137
X Ray, fluoroscopy systems
MHRA reference: 2017/005/025/291/031
GE Healthcare Medical Systems
5 May 2017
Monitors, Patient
Model: Dash 4000
MHRA reference: 2016/011/018/401/012
Leica Microsystems: Leica M525 F40
05 May 2017
Surgical equipment, miscellaneous
MHRA reference: 2017/005/019/291/019
Philips Medical Systems: DigitalDiagnost
18 April 2107
X Ray, digital acquisition systems
Model: 712026
MHRA reference: 2017/005/019/291/006
Philips Healthcare: IntelliVue NMT Patient Cable
26 April 2017
Monitors, patient
Model: Philips IntelliVue NMT Patient Cables (989803174581)
MHRA reference: 2017/005/019/291/010
Medos International: LATARJET EXPERIENCE
18 May 2017
Orthopaedic surgical instruments - Insertion/extraction tools
Model: 288211, 288201, 288202, 288203, 288216
MHRA reference: 2017/005/023/291/027
Medtronic MiniMed: MiniMed 640G Insulin Pump, MMT-1711, MMT-1712
May 2017
Infusion systems
MHRA reference: 2017/005/025/291/023
Molnlycke: Brennen® Skin Graft Mesher
17 May 2017
Surgical power tools
MHRA reference: 2017/005/023/291/024
Mölnlycke Health Care: See attached Product Table
23 May 2017
Sutures
MHRA reference: 2017/005/023/701/015
Nutricia Medical Devices: Flocare Gastrostomy tube (G-tube) - ENFit
24 May 2017
Feeding systems and tubes
Model: Ch10, Ch14, CH16, Ch18, Ch20
MHRA reference: 2017/005/022/291/021
Roche: cobas p 512 pre-analytical system (model number: 07563124001)
cobas p612 pre-analytical system (model number: 07563116001)
16 May 2017
IVDs, clinical chemistry
MHRA reference: 2017/005/019/701/020
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS: Beneview T1 Patient Monitor
March 2017
Monitors, patient
MHRA reference: 2017/004/020/701/007
St Jude Medical:Nanostim™ Leadless Pacemaker
FA2017-05
Implants, active, pacemakers
Model: LSP102
MHRA reference: 2017/005/011/701/022
Stryker Instruments-Kalamazoo: Stryker SmartLife Large Aseptic Housings
March 2017
Surgical power tools
Model: 7126-120-000
MHRA reference: 2017/003/020/291/020
Zimmer Biomet: Vitality Spinal Fixation System
24 May 2017
Orthopaedic surgical instruments - insertion/extraction tools
MHRA reference: 2017/005/025/701/004