Field Safety Notice - 18 to 22 June 2018
Summary List of field safety notices (FSNs) from medical device manufacturers from 18 to 22 June 2018.
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
Becton Dickinson: All Alaris Syringe Driver models
June 2018
Infusion systems
MHRA reference: 2018/006/020/081/027
Boston Scientific: Maestro Cardiac Ablation System
20 June 2018
Therapy tissue ablation
Model: Maestro 4000 Footswitch: M004218500- Maestro 4000 Footswitch M00421850D0- Maestro 4000 Footswitch, Demo M00421850H0- Maestro 4000 Footswitch, Hospital Owned M00421850R0- Maestro 4000 Footswitch, Repaired M00421850Z0- Maestro 4000 Footswitch, Zero Cost Maestro Pump to Generator Cable: M004315000- Cable OI Pump to OI Maestro Maestro 4000 Controller: M00440000- Maestro 4000 Controller M0044000D0- Maestro 4000 Controller, Demo M0044000H0- Maestro 4000 Controller, Hospital Owned M0044000R0- Maestro 4000 Controller, Repaired M0044000Z0- Maestro 4000 Controller, Zero Cost
MHRA reference: 2018/006/020/291/012
CareFusion: Airlife™ Manual Resuscitator
June 2018
Resuscitators
MHRA reference:2018/006/018/291/007
Ethicon:Ultrasonic Surgical System Handpiece Tip
2 May 2018
Surgical power tools
MHRA reference: 2018/005/009/478/001
Fukuda Densh: Fukuda Denshi ECG Trolley
6 April 2018
Trolleys and chairs
Model: OTE-02
MHRA reference: 2018/004/017/601/008
GE Medical Systems: Discovery MR750w
GEHC Ref 60937
Magnetic resonance, equipment & accessories
MHRA reference: 2018/006/019/291/029
Leica: Bond
IR27/18
IVDs, cytopathology & histopathology
Model: DS9800
MHRA reference: 2018/006/014/601/011
Leica: HistoCore Spectra ST
June 2018
IVDs, cytopathology & histopathology
Model: 14051254354
MHRA reference: 2018/006/007/291/002
Medicrea International: IMPIX MANTA prefilled on holder
13 June 2018
Spinal implants
Model: B20171743, B20171963, B20171973
MHRA reference: 2018/006/018/291/020
Medline Industries: Bocal d'aspiration MED-RIGID 2L
12 June 2018
Surgical equipment, miscellaneous
MHRA reference: 2018/006/014/291/002
Philips Healthcare (IGT System): Allura Xper, UNIQ, and Centron
22 June 2018
X Ray, fluoroscopy systems
MHRA reference: 2018/006/019/291/016
Philips Medical: Patient support
21 March 2018
X Ray, general
Model: 989001087431
MHRA reference: 2018/006/020/081/031
Radiometer: TCM5 Calibration Gas
FAN 915-379
Monitors, foetal
MHRA reference: 2018/003/014/228/004
Smith & Nephew: Journey Oxinium Knee
13 June 2018
Joint prosthesis, knee
MHRA reference: 2017/009/007/264/002
Smith & Nephew: SUTURE ANCHOR DEVICES
04 June 2018
Sutures
MHRA reference: 2018/006/005/478/012
Smith & Nephew: Legion HK Tibial Base SZ 5 Left
R-2018-25
Joint prosthesis, knee
MHRA reference: 2018/006/019/701/008
St. Jude Medical: CardioMems Hospital and Patient Electronic System
14 June 2018
Implants, active, monitors and recorders
Model: CardioMems Hospital and Patient Electronic System CM3000, CM1100
MHRA reference: 2018/006/013/291/001
WG Healthcare: CT011, CT012, MI Screw
10 May 2018
Osteosynthesis, bone screws
MHRA reference: 2014/006/012/401/003
Last updated 27 June 2018 + show all updates
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Inserted Philips Healthcare (IGT System): Allura Xper, UNIQ, and Centron
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First published.