Field safety notices - 22 to 26 June 2015

List of field safety notices (FSNs) from medical device manufacturers from 22 to 26 June 2015.


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

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: 2015/006/008/291/004

American Medical Systems (AMS): reusable stripper and cleaver accessories used with Aura Fibers


Therapy, lasers

Model: various models

MHRA reference: 2015/006/019/291/016

American Medical Systems (AMS): SureFlex™ reusable fibers and reusable stripper and cleaver accessories


Therapy, lasers

Model: various models

MHRA reference: 2015/006/022/291/010

Depuy Synthes: Pull reduction device for percutaneous drill guide Æ4.3mm

19 June 2015

Surgical instruments, implant

Model: 03.130.023

MHRA reference: 2015/006/022/291/006

EIT Emerging Implant Technologies:EIT PLIF shaver

12 June 2015

Surgical instruments, non-articulated cutting

Model: PET10700, PET10900, PET11100; PET11300, PET11500

MHRA reference: 2015/006/023/291/008

GE Healthcare: D-Fend/D-Fend+ water traps

GEHC Ref# 36111

Anaesthetic machines & monitors

MHRA reference: 2015/006/025/291/002

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: 2015/006/019/701/003

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: 2015/006/022/291/011

Lifecell Corporation: Strattice reconstructive tissue matrix

23 June 2015

Dermal substitutes, tissue scaffolds

MHRA reference: 2015/006/024/291/004

Medicina: Medicina blue automatic safety syringes

23 June 2015

Injection devices

Model: RN03/21 and RN05/21

MHRA reference: 2015/006/025/601/007

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: 2015/006/022/291/008

Nobel Biocare: Abutment retrieval Instr Zr CC RP/WP

23 June 2015

Implants, dental

Model: 37882 (Instrument) and 37508 (Kit)

MHRA reference: 2015/006/019/701/005

NRT-Nordisk Røntgen Teknik: Precision 500D - Precision Rxi - Precision MPi

FMI 10903

X-ray, fluoroscopy systems

MHRA reference: 2015/006/025/291/003

Ortho Solutions: RFS wire fixation bolt slotted

19 June 2015

Osteosynthesis, external fixators

Model: OS162000

MHRA reference: 2015/006/019/291/006

Perouse Medical: Polymaille Extra Thin vascular prosthesis

1 June 2015

Implants, non-active, surgical vascular grafts and patches

MHRA reference: 2015/006/008/291/010

Philips Medical Systems: Philips Expression MRI patient monitoring system

June 2015

Multi parameter monitor

Model: 865214

MHRA reference: 2015/006/023/291/010

Siemens AG Medical Solutions: Artis systems

15 June 2015

X-ray, fluoroscopy systems

Model: 10280959 / 10280959

MHRA reference: 2015/005/006/291/004

Sartorius Stedim Biotech

30 March 2015

Injection devices

Model: Minisart, 16534-K

MHRA reference: 2015/005/005/291/028

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: 2015/006/025/291/007

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