Field Safety Notices - 25 July - 29 July 2016

Summary List of field safety notices (FSNs) from medical device manufacturers from 25 - 29 July 2016

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

Agfa Healthcare: DX-D 600

PRB0052065 - VR0000310

X Ray, digital acquisition systems

MHRA reference: 2016/004/027/701/017

Alere Technologies AS: Alere Afinion™ CRP

July 2016

IVDs, clinical chemistry

MHRA reference: 2016/007/025/701/002

Bausch + Lomb: 1,5 mmx1,7mm TRAPEZOID ANGLED 6/BOX MAXZ170

27 June 2016

Surgical instruments, non-articulated cutting Model: 1,5 mmx1,7mm TRAPEZOID ANGLED 6/BOX MAXZ170 E7599

MHRA reference: 2016/006/030/291/003

Biomet: BIOMET 360 TIBIAL AUG

6 April 2016

Joint prosthesis, knee

MHRA reference: 2016/004/008/701/008

CSC: iLAB

20 June 2016

IVDs, clinical chemistry

MHRA reference: 2016/007/025/299/002

Cellnovo: Cellnovo

15 July 2016

Infusion systems Model: 2000041

MHRA reference: 2016/007/015/601/007

Covidien: Covidien Valleylab™ Laparoscopic Electrodes

15 July 2016

Surgical, diathermy MHRA reference: 2016/007/014/701/008

Hangzhou Biotest Biotech: RightSign HIV 1.2.O Rapid Test Cassette RightSign HCV Rapid Test Cassette RightSign HBsAg Rapid Test Cassette

20 June 2016

IVDs, viral microbiology

MHRA reference: 2016/006/020/291/004

Intuitive Surgical: da Vinci Xi EndoWrist Stapler (Stapler 45, Stapler 30, Stapler 30 Curved-Tip)

22 July 2016

Endoscopes, rigid

Model: 470298, 470430, 470530

MHRA reference: 2016/007/025/299/006

Maquet: CARDIOSAVE Hybrid IABP, CARDIOSAVE Rescue IABP

14 June 2016

Cardiac assist pumps MHRA reference: 2016/007/021/291/001

McKesson: McKesson Radiology (MR)

12 July 2016

Picture archiving and communication system Model: McKesson Radiology (MR) 12.1.1

MHRA reference: 2016/007/021/291/005

Medtronic: O-arm® 1000 Surgical Imaging System, O-arm® O2 Surgical Imaging System

July 2016

X Ray, fluoroscopy systems MHRA reference: 2016/007/020/299/002

Merge: Merge CADstream

13 July 2016 (2016-022)

Picture Archiving and Communication System (PACS) MHRA reference: 2016/006/028/601/024

Merge: Merge CADstream

13 July 2016 (2016-023/024)

Picture Archiving and Communication System (PACS) MHRA reference: 2016/006/028/601/015

Merge: Eye Station

13 July 2016

Picture Archiving and Communication System (PACS)

MHRA reference: 2016/006/028/601/009

Merge: Eye Station

13 July 2016 (2016-044)

Picture Archiving and Communication System (PACS) MHRA reference: 2016/006/029/601/010

Merge: Eye Station

13 July 2016 (2016-039)

Picture Archiving and Communication System (PACS) MHRA reference: 2016/006/028/601/014

Merge: iConnect Enterprise Archive

13 July 2016 (2016-067)

Picture Archiving and Communication System (PACS) MHRA reference: 2016/006/028/601/021

Merge: iConnect Enterprise Archive

13 July 2016 (2016-059)

Picture Archiving and Communication System (PACS) MHRA reference: 2016/006/028/601/013

Merge: iConnect Enterprise Archive

13 July 2016 (2016-062)

Picture Archiving and Communication System (PACS) MHRA reference: 2016/006/028/601/012

Merge: Merge PACS

13 July 2016 (2016-009)

Picture Archiving and Communication System (PACS) MHRA reference: 2016/006/028/601/008

Merge: Merge PACS

13 July 2016 (2016-012)

Picture Archiving and Communication System (PACS) MHRA reference: 2016/006/028/601/019

Merge: Merge PACS

13 July 2016 (2016-033)

Picture Archiving and Communication System (PACS) MHRA reference: 2016/006/028/601/018

Merge: Merge PACS

13 July 2016 (2016-010)

Picture Archiving and Communication System (PACS) MHRA reference: 2016/006/028/601/017

Merge: Merge PACS

13 July 2016 (2016-034)

Picture Archiving and Communication System (PACS) MHRA reference: 2016/006/028/601/016

Merge: Merge PACS

13 July 2016 (2016-051)

Picture Archiving and Communication System (PACS) MHRA reference: 2016/006/028/601/011

MoNo: ULTRASTOP pro med

June 2016

Endoscopes, flexible

MHRA reference: 2016/007/013/299/010

Newdeal: Large Qwix® Positioning screws

13 July 2016

Osteosynthesis, bone screws Model: 121530S, 121535S, 121540S,121545S, 121550S, 121555S, 121560S, 121565S, 121570S, 121575S, 121580S, 121740S, 121745S, 121750S, 121755S, 121760S, 121765S, 121770S, 121775S, 121780S, 121785S, 121790S, 121795S, 121800S, 121805S, 121810S, 121815S, 121820S

MHRA reference: 2016/007/022/299/015

Novus Scientific AB: TIGR Matrix Surgical Mesh

19 July 2016

Implants, non-active, abdominal & hernia mesh

Model: NSTM1015E, NSTM1520E, NSTM2030E

MHRA reference: 2016/007/025/701/001

Ortho Solutions: Foot Plating System

21 July 2016

Osteosynthesis, bone screws

Model: OS326835

MHRA reference: 2016/007/022/299/019

Philips: Ingenuity Core128

21 July 2016

Computed tomography Model: 728323

MHRA reference: 2014/004/008/081/044

Smith & Nephew: Sterile RENASYS™ Transparent Film RENASYS™ Dressing kits that contain the folded RENASYS™ Transparent Film

21 July 2016 (WR-2016-03)

Active wound management

MHRA reference: 2016/007/022/701/013

Smith & Nephew: WHIPKNOT Soft Tissue Cinch #5 Sutures

21 July 2016

Suture non absorbable MHRA reference: 2016/007/022/299/001

Siemens: Xprecia Stride Coagulation Analyzer

July 2016

Coagulation

MHRA reference: 2016/007/026/601/003

Siemens: ADVIA Chemistry XPT System

25 July 2016

IVDs, clinical chemistry

Model: SMN 10723034

MHRA reference: 2016/007/026/601/002

Siemens: AXIOM Artis; Artis zee; Artis Q/Q zen

27 June 2016

X Ray, fluoroscopy systems Model: various

MHRA reference: 2016/007/015/601/001

Siemens: Artis zee; verschiedene - various / verschiedene -various

15 February 2016

X Ray, fluoroscopy systems Model: Cardio/Angio System, systems with generator A100plus, Artis zeego systems mit Software VC21B

MHRA reference: 2016/003/014/292/011

Sorin Group: PLATINUM

27 July 2016

Implants, active, defibrillators

Model: PLATINIUM VR 1210, PLATINIUM DR 1510, PLATINIUM CRT-D 1711

PLATINIUM SonR CRT-D 1811, PLATINIUM VR 1240, PLATINIUM DR 1540, PLATINIUM CRT-D 1741, PLATINIUM SonR CRT-D 1841, PLATINUM

MHRA reference: 2016/007/028/299/001

The Binding Site: Optilite Analyser

15 July 2016

IVDs, immunology MHRA reference: 2015/005/007/601/006

Trinity Biotech: Captia™ Malaria EIA

19 July 2016

IVDs, bacteriology

MHRA reference: 2016/007/022/299/026

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