Field Safety Notice - 8 to 12 January 2018
Summary List of field safety notices (FSNs) from medical device manufacturers from 8 to 12 January 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
BioMerieux SA: MINI VIDAS ANALYSER VIDAS ANALYSER Quality Control VIDAS
09 January 2018
IVDs, viral microbiology
MHRA reference: 2018/001/010/000/001
Boston Scientific Corporation(Stryker): Guider Softip TM XF Guide Catheter
03 January 2018
Vascular cannula and catheters
MHRA reference: 2017/012/022/291/022
GE Medical Systems: 9100c/Aelite
January 2018
Anaesthetic machines & monitors
MHRA reference: 2018/001/010/000/012
Gebrueder Martin: LASER PROT.GOGGLES UNIV Nd:YAG,CO2,DIODE
29 December 2017
Therapy, lasers
Model: LASER PROT.GOGGLES UNIV Nd:YAG,CO2,DIODE 79-100-56-04
MHRA reference: 2018/001/011/291/004
ICU Medical: Plum 360 (30010) Infusion Pump
21 June 2017
Infusion systems
Model: Plum 360 (30010)
MHRA reference: 2017/006/013/291/012
Implant Direct: SwishTapered™ Implant / SwishPlus™ Implant
January 2018
Implants, dental
Model: 934106, 934806, 934812, 934814, 924116, 924810W, 924814, 924108, 924112, 924806, 924112, 924812W, 934106, 934112, 935712
MHRA reference: 2018/001/006/601/001
Integra LifeSciences (Ascension Orthopedics): TITAN (TSS) Humera Stem Trials
28 December 2017
Joint prosthesis, shoulder
MHRA reference: 2017/012/021/291/036
Medos International Sarl
January 2018
Surgical instruments, non-articulated cutting
Model: 288204 LATARJET EXPERIENCE Sharp Curve Ostetome
MHRA reference: 2018/001/009/291/023
Menicon: MeniCare Soft 70ML
04 January 2018
Contact Lenses, Care Products
MHRA reference: 2018/001/009/291/007
Philips Healthcare: Intellivue iX Information Center Software
3 January 2018
Monitors, patient
Model: 866023, 866117, 866389, 867141
MHRA reference: 2018/001/011/291/008
Philips Medical Systems (Cleveland): Precedence
BrightView X BrightView SPECT BrightView XCT
15 December 2017
Nuclear Medicine, Gamma Camera Systems & Accessories
Model: 882350 Precedence 16 882351 Precedence 6 Slice 882478 BrightView X 882480 BrightView SPECT 882482 BrightView XCT
MHRA reference: 2018/001/009/000/014
Siemens: syngo Workflow MLR
18 December 2017
Picture archiving and communication system (PACS)
MHRA reference: 2018/001/005/601/011
Siemens Healthcare Diagnostics: Advia Centaur DHEAS, Advia Centaur CSA, Advia Centaur Folate, Advia Centaur HBc IGM
January 2018
IVDs, clinical chemistry
Model: DHEAS, CSA, Folate, HBc IGM assays run on Advia Centaur
MHRA reference: 2018/001/005/601/007
Source BioScience: FIXOL (Fixative for Kleihauer)
20 December 2017
IVDs, blood transfusion
Model: 05-051
MHRA reference: 2017/012/022/601/008