Field safety notices - 22 to 26 June 2015
List of field safety notices (FSNs) from medical device manufacturers from 22 to 26 June 2015.
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
Agfa HealthCare: AGFA digital radiography X-ray system DX-D 100
PR1501190003 PR1411200006PR1406020002
X-ray, digital acquisition systems
Model: DX-D 100 mobile wireless DR
MHRA reference:
American Medical Systems (AMS): reusable stripper and cleaver accessories used with Aura Fibers
AuraFibers
Therapy, lasers
Model: various models
MHRA reference:
American Medical Systems (AMS): SureFlex鈩� reusable fibers and reusable stripper and cleaver accessories
SureFlexReusableFibers
Therapy, lasers
Model: various models
MHRA reference:
Depuy Synthes: Pull reduction device for percutaneous drill guide 脝4.3mm
19 June 2015
Surgical instruments, implant
Model: 03.130.023
MHRA reference:
EIT Emerging Implant Technologies:EIT PLIF shaver
12 June 2015
Surgical instruments, non-articulated cutting
Model: PET10700, PET10900, PET11100; PET11300, PET11500
MHRA reference:
GE Healthcare: D-Fend/D-Fend+ water traps
GEHC Ref# 36111
Anaesthetic machines & monitors
MHRA reference:
Intuitive Surgical: da Vinci Xi Endowrist instruments
16 June 2015
Sterilization, healthcare
Model: 470001, 470006, 470033, 470048, 470093, 470171, 470172, 470179, 470181, 470183, 470184, 470205, 470207, 470215, 470230, 470246, 470249, 470309, 470318, 470327, 470344, 470347
MHRA reference:
JustRight Surgical: JustRight 5mm stapler, JustRight 5mm reload
18 June 2015
Staples and staple guns
Model: JR-ST2S-2.0, JR-REL2S-2.0
MHRA reference:
Lifecell Corporation: Strattice reconstructive tissue matrix
23 June 2015
Dermal substitutes, tissue scaffolds
MHRA reference:
Medicina: Medicina blue automatic safety syringes
23 June 2015
Injection devices
Model: RN03/21 and RN05/21
MHRA reference:
Medtronic MiniMed: Medtronic MiniMed 640G insulin pump
19 June 2015
Infusion systems
Model: Pump: MMT-1511, MMT-1711 Pump kit: MMT-1551, MMT-1751
MHRA reference:
Nobel Biocare: Abutment retrieval Instr Zr CC RP/WP
23 June 2015
Implants, dental
Model: 37882 (Instrument) and 37508 (Kit)
MHRA reference:
NRT-Nordisk R酶ntgen Teknik: Precision 500D - Precision Rxi - Precision MPi
FMI 10903
X-ray, fluoroscopy systems
MHRA reference:
Ortho Solutions: RFS wire fixation bolt slotted
19 June 2015
Osteosynthesis, external fixators
Model: OS162000
MHRA reference:
Perouse Medical: Polymaille Extra Thin vascular prosthesis
1 June 2015
Implants, non-active, surgical vascular grafts and patches
MHRA reference:
Philips Medical Systems: Philips Expression MRI patient monitoring system
June 2015
Multi parameter monitor
Model: 865214
MHRA reference:
Siemens AG Medical Solutions: Artis systems
15 June 2015
X-ray, fluoroscopy systems
Model: 10280959 / 10280959
MHRA reference:
Sartorius Stedim Biotech
30 March 2015
Injection devices
Model: Minisart, 16534-K
MHRA reference:
Verathon Medical: GlideScope video laryngoscope
19 June 2015
Airway devices
Model: GVL 3, GVL 4, GVL 5, AVL 2, AVL 3, AVL 4, AVL 5
MHRA reference: