Field safety notices - 6 to 13 July 2015

List of field safety notices (FSNs) from medical device manufacturers from 6 to 13 July 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

Baxter Healthcare: sterile water for irrigation, 1000 ml (code UKF7114) 0.9% sodium chloride for irrigation, 1000 ml (code UKF7124)

July 2015

Surgical equipment, miscellaneous

MHRA reference: 2015/007/006/291/013

Brainlab AG: iPlan RT Dose

12 June 2015

Radiotherapy planning and verification systems

MHRA reference: 2015/007/003/701/007

CareFusion: Vital Signs Light Wand stylet and Light Wand pack

June 2015

Airway devices

MHRA reference: 2015/007/008/291/001

Depuy Synthes: Technique guide reamer/irrigator/aspirator (RIA)

01 July 2015

Surgical instruments, implant

Model: 036.000.553

MHRA reference: 2015/007/007/291/009

Dräger Medical: Sola 500/700; G93358, G93359

May 2015

Lamps & lights

MHRA reference: 2015/007/009/291/007

Dräger Medical: Evita Infinity V500, Babylog VN500, Evita V300

June 2015

Lung ventilators

MHRA reference: 2015/007/007/291/002

Medtronic: Engager Bioprosthesis

July 2015

Implants, non-active, cardiovascular heart valves

Model: Percutaneous Valve / Transcatheter Valve –Thv ME-TA2-823

MHRA reference: 2015/006/024/291/007

Philips Medical: ACS-NT, Intera 1.5T, Achieva 1.5T

June 2015

Magnetic resonance, equipment & accessories

Model: 78107, 781105, 781105, 781106, 781107, 781108, 781153, 781160, 781170, 781171, 781172, 781173, 781174, 781175, 781176, 781178, 781195, 781196, 781253, 781283, 781295, 781296, 781343, 781346, 781382

MHRA reference: 2015/007/007/291/014

Pulsion Medical Systems: PiCCO catheter

30 June 2015

Vascular cannula and catheters

Model: PV2014L08-A and PV2014L50-A

MHRA reference: 2015/007/009/701/015

Roche Diagnostics: Reflotron uric acid test

01 July 2015

IVDs, extra laboratory testing

Model: Reflotron uric acid, Reflotron PST uric acid, and Reflotron uric acid II

MHRA reference: 2015/007/006/701/008

Siemens Healthcare: ARTIS ZEE floor; ARTIS ZEE ceiling

15 June 2015

X-ray, fluoroscopy systems

MHRA reference: 2015/007/007/601/509

Siemens Medical Solutions: E. CAM

MI008/15/S including MI009/15/S

Nuclear medicine, gamma camera systems & accessories

Model: 4380213, 4380221, 10520745, 5242826, 5977066, 5977074

MHRA reference: 2015/007/007/601/503

Siemens Medical Solutions: ACUSON S family (S1000, S2000, S3000)

UI US013/15/S

Ultrasound, imaging

Model: 10441701, 10041461, 10441730, 10440017

MHRA reference: 2015/007/007/601/504

Siemens Medical Solutions: ACUSON S2000, S3000 with virtual touch IQ option

UI US014/15/S

Ultrasound, imaging

Model: 10041461, 10440017 and 10441730

MHRA reference: 2015/007/007/601/505

Siemens Medical Solutions: ACUSON S family

UI US016/15/S

Ultrasound, imaging

Model: 10041461, 10441701, 10441730

MHRA reference: 2015/007/007/601/506

Stryker Trauma: rHead, uHead, Sigmoid Notch, ReMotion, Radio Capitellum

03 July 2015

Joint prosthesis, elbow

Model: see FSN

MHRA reference: 2015/007/007/291/001

Thermofisher Scientific: Oxoid MacConkey Agar No. 3 (DCM)

7 July 2015

IVDs, bacteriology

Model: CM0115B

MHRA reference: 2015/007/009/601/003

TRUMPF Medizin Systeme: klinoPORT

24 June 2015

Examination/treatment lamp

Model: 4027210; 4027410; 4027510

MHRA reference: 2015/007/003/701/002

Vygon SA - c/o Vygon: Y connector 8-10mm

3 July 2015

Infusion & transfusion, administration sets

Model: 0884.08

MHRA reference: 2015/007/003/601/501

Zethon: Monopolar and bipolar cables

08 July 2015

Surgical, diathermy

MHRA reference: 2015/006/030/291/003

Zimmer Biomet UK: RHK knee femoral component

30 June 2015

Joint prosthesis, knee

MHRA reference: 2015/007/006/291/001

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