Field safety notices - 15 to 19 June 2015

List of field safety notices (FSNs) from medical device manufacturers from 15 to 19 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

View the latest FSNs

.3M ESPE Dental Products: 3M ESPE Lava Ultimate

3005174370 06022015-001-C-GB

Dental materials

MHRA reference: 2015/006/018/291/006

ArthroCare Corporation: PROCISE EZ VIEW

10 June 2015

Surgical, diathermy

MHRA reference: 2015/006/015/291/017

Bedfont Scientific: NOxBOX

8 June 2015

Nitric oxide delivery system

MHRA reference: 2015/001/020/601/007

bioMerieux: Etest® Cefotaxime CT 256

15 June 2015

IVDs, bacteriology

MHRA reference: 2015/006/015/291/029

Biomet: Oxford femoral drill guide lateral IM adapter

11 June 2015

Surgical instruments, implant

MHRA reference: 2015/006/015/291/006

Boston Scientific: Clearsign II amplifier

91046622-FA

Diagnostic measurement and monitoring

Model: CLEARSIGN™ II amplifier for LABSYSTEM™ PRO EP recording system

MHRA reference: 2015/006/012/051/006

Cook Incorporated

28 May 2015

Surgical instruments, minimal access

Model: Cook LapSac® surgical tissue pouch

MHRA reference: 2015/006/011/701/002

Curefab Technologies: Curefab CS

FT-2248

Ultrasound, imaging

MHRA reference: 2015/006/015/291/023

Depuy Synthes: Guide wire 2.8mm, L 180mm w/ thread

11 June 2015

Surgical instruments, implant

Model: 03.007.020

MHRA reference: 2015/006/017/291/009

Dermaroller: Transdermal needle roller, single-use

7 May 2015

Device description: Surgical devices, non-powered

Model: Dermaroller MC: MC415, MC905, MC915

MHRA reference: 2015/005/019/131/003

Handicare: ReTurnBelt wipeable

15 June 2015

Moving and handling

Model: 6133, 6134, 6135, 6136

MHRA reference: 2015/006/017/291/010

Labor Dr. Merk & Kollegen: Hemolytic system

13 April 2015

IVDs, clinical chemistry

Model: HS-020, HS-023, HS-050, HS-053, HS-100, HS-103

MHRA reference: 2015/006/012/291/001

MAQUET: MAGNUS Hybrid OR table column

21 May 2015

Operating table

Model: 1180.01B2

MHRA reference: 2015/005/021/701/005

Medtronic: DLP® femoral arterial cannula and DLP® femoral cannula and insertion kits

June 2015

Vascular cannula and catheters

Model: 57414, 57417, 57421, Kit 96017, 96021

MHRA reference: 2015/006/012/051/004

Merit Medical Systems: Merit prelude sheath introducer

Prelude® Sheath Introducer Recall

Vascular cannula/catheter accessories

Model: PRO-6F-11-038, Lot H767887

MHRA reference: 2015/006/018/291/002

Philips Medical Systems DMC: MobileDiagnost wDR

19 May 2015

Direct digital radiography

Model: 712001/712002

MHRA reference: 2015/006/018/291/007

PTW Freiburg: UNIDOS webline

11 May 2015

Radiotherapy planning and verification systems

Model: T10021, T10022, T10023

MHRA reference: 2015/006/015/291/025

Roche Diagnostics: S3 fluid pack A, SS2 fluid pack

12 June 2015

IVDs, extra laboratory testing

MHRA reference: 2015/006/017/291/004

Siemens: Cios Alpha; 10308191

Siemens - UI XP015-15-S and UI XP018-15-S

X-ray, mobiles

MHRA reference: 2015/006/016/291/009

Siemens Healthcare Diagnostics: IMMULITE and 1000 sample cup holder set / IMMULITE 2000 microsampling tube holder set

June 2015

IVDs, clinical chemistry

Model: SMNs 10385360 / 10385319 /10385209

MHRA reference: 2015/006/012/601/004

Stryker Leibinger Freiburg: Navigation System II-Cart

18 May 2015

Surgical navigation system

MHRA reference: 2015/006/015/291/022

Zethon: REM-DF02, REM-DF04, REM-DF06, REM-DF07 - all batches

16 June 2015

Pacemakers, external

MHRA reference: 2015/006/008/291/002

Zethon: REM-101, REM-101-D, REM-101-SP, REM-102, REM-102-D, REM-103, REM-103-D, REM-104, REM-104-D, REM-105, REM-105-D, - all batches

8 June 2015

Surgical, diathermy

MHRA reference: 2015/006/008/291/007

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