Field Safety Notice - 03 April to 07 April 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 03-07 April 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 Vascular:Absorb Bioresorbable Vascular Scaffold System
31 March 2017
Implants, non active, coronary stents
Model: See FSN
MHRA reference: 2017/003/029/299/010
Bracco Injeneering: CT Exprès 3D Temperature Maintainer Model
25 March 2017
Media injectors
Model: 650207 (CT Exprès 3D)
MHRA reference: 2017/004/003/601/006
CareFusion: Alaris™ GS, GH, CC, TIVA, PK, Enteral Syringe Pump; Asena™ GS, GH, CC, TIVA, PK Syringe Pumps
March 2017
Infusion systems
Model: 8001, 8002, 8003, 8004, 8005, 8007; 8001, 8002, 8003, 8004, 8005
MHRA reference: 2017/003/031/299/034
Gryphus Diagnostics:OSOM BVBLUE Test
3 April 2017
IVDs, bacteriology
MHRA reference: 2017/004/005/701/013
Helena Laboratories: Cascade Abrazo c-ACT-LR
05 April 2017
Coagulation
MHRA reference: 2017/003/013/299/025
Medtronic: Newport HT70 Ventilators
April 2017
Lung ventilators
MHRA reference: 2017/004/005/601/009
Mizuho: Wilson Frame Pads
28 March 2017
Pressure relief cushions
Model: 5319-37
MHRA reference: 2017/003/030/601/014
SALVIA: elisa 600, elisa 800, elisa 800 VIT
6 March 2017
Lung ventilators
MHRA reference: 2017/003/031/701/004
Natus: neoBLUE LED Phototherapy System; 010066, 010068, 010069, 010070
March 2017
Therapy, infant phototherapy
MHRA reference: 2017/004/005/701/004
NIHON KOHDEN: Life Scope G9
April 2017
Monitors, patient
Model: Life Scope G9; CSM-1901
MHRA reference: 2017/004/003/701/012
ORGENTEC: ORG 247 Anti-Intrinsic Factor
29 November 2016
IVDs, immunology
MHRA reference: 2017/003/031/701/018
Philips: Allura Xper Systems, CV20 Systems and UNIQ systems
09 March 2017
X-ray, fluoroscopy systems
Model: The following systems are only affected if a Laird chiller is installed (11NC: 98960021599):
MHRA reference: 2017/003/031/299/024
SSI Diagnostica: Immuview® S. pneumoniae and L. pneumophila urinary
24 March 2017
IVDs, bacteriology
MHRA reference: 2017/003/031/299/026
St. Jude Medical: Merlin@Home Transmitter
3 April 2017
Implants, active, defibrillators
Model: EX1150, EX1150W, EX1100, and EX1100W
MHRA reference: 2017/004/003/701/020
Smith & Nephew: Radial Osteotome Blade
31 March 2017
Surgical instruments, non articulated cutting
MHRA reference: 2017/003/031/701/020
Siemens: Dimension TNI, DimnesioV DIGXN, E2, FERR, PRL, TSH
March 2017
IVDs, clinical chemistry
Model: Dimension TNI, DimnesioV DIGXN, E2, FERR, PRL, TSH
MHRA reference: 2017/004/003/601/004
aap Implantate: Annex A: Item 6 Information on the medical device
15 March 2017
Osteosynthesis, bone screws
MHRA reference: 2017/004/004/701/013