Field Safety Notices: 7 to 11 September 2020
Summary list of field safety notices (FSNs) from medical device manufacturers from 7 to 11 September 2020.
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
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Across: Revolax, Dermalax, dermaren
1 September 2020
Implants, reconstructive, body contouring
MHRA reference
Advanced Medical Solutions: ACTIVHEAL Hydrogel
02 September 2020
Haemostatic agents
Model: 10014007
MHRA reference
Armstrong Medical: Catheter Mounts
10 September 2020
Breathing system components
MHRA reference:
Caesarea Medical Electronics: T34 Ambulatory Syringe Pump
07 September 2020
Infusion systems
MHRA reference:
Getinge - MAQUET: mobile OR-Table MEERA, YUNO und YUNO II
2020-09-08
2020-010
Operating table
Model: 720001B2, 720001B0, 720001F2, 720001F0, 710001B2, 710001B0, 143301B0, 143301F0, 143302B0, 143302F0
MHRA reference:
ICU Medical: Spiros
08 September 2020
Infusion & transfusion, connectors
MHRA reference:
Lifemax UK: Hearing aid
4 September 2020
Disabled peoples鈥� aids
MHRA reference:
Medtronic: Rashkind庐 Balloon Septostomy Catheters
September 2020
Vascular cannula and catheters
Model: 007160, 007161, 008764
MHRA reference:
Micro Therapeutics (Medtronic): PipelineTM Flex Embolization Device (with Shield TechnologyTM)
September 2020
Intracranial flow diverters / stents
Model: PED-250-XX, PED-275-XX, PED-300-XX, PED-325-XX, PED-350-XX, PED-375-XX, PED-400-XX, PED-425-XX, PED-450-XX, PED-475-XX, PED-500-XX, PED2-250-XX, PED2-275-XX, PED2-300-XX, PED2-325-XX, PED2-350-XX, PED2-375-XX, PED2-400-XX, PED2-425-XX, PED2-450-XX, PED2-475-XX, PED2-500-XX
MHRA reference:
Nouvag AG: MD11 / MD30
11 August 2020
Dental, laboratory equipment
MHRA reference:
Olympus: OES CHOLEDOCHOFIBERSCOPE - OLYMPUS CHF TYPE CB30S
September 2020
Endoscopes, flexible
Model: CHF-CB30S
MHRA reference:
Philips: Efficia DFM 100
11 August 2020
Defibrillators, non-Implantable
Model: 866199
MHRA reference:
Pressalit A/S: VALUE II
08 September 2020
Bath and aids
Model: R1610
MHRA reference:
Siemens: ADVIA Centaur HER-2/neu (H2n) Assay and ADVIA Centaur
August 2020
IVDs, clinical chemistry
MHRA reference:
Thermo Fisher: Oxoid
03 September 2020
IVDs, bacteriology
Model: CT0034B
MHRA reference:
Vascular Solutions (Teleflex)
08 September 2020
Vascular cannula and catheters
Model: 5515; 5540; 5545; 5550
MHRA reference: