Field Safety Notice: 18 to 22 March 2019

List of field safety notices (FSNs) from medical device manufacturers from 18 to 22 March 2019.

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

BioFire Diagnostics: BioFire Diagnostics

15 March 2019

IVDs, bacteriology

MHRA reference: 2019/003/018/487/034

Carestream: Quantum

15 March 2019

X Ray, ancillary equipment and accessories

Model: DRX-Ascend System and Q-Rad System

MHRA reference: 2019/003/019/487/012

ConMed: Anchor Tissue Retrieval System™

March 2019

Surgical instruments, minimal access

MHRA reference: 2019/003/020/701/011

Cordis: Cordis Vista Brite and ADROIT Guiding Catheter

06 March 2019

Vascular cannula and catheters

MHRA reference: 2019/002/008/487/033

Geistlich Pharma: Geistlich Bio-Oss Pen

19 March 2019

Implants, dental

Geistlich Bio-Oss Pen

MHRA reference: 2019/003/020/701/012

Hugh Stepper: Select Myoelectric Hand

RTA N° 9999

Upper limb prosthesis

MYA725RNA - Serial N°1125

MHRA reference: 2019/003/019/601/007

Leica: Leica Biosystems Cryostats

March 2019

IVDs, cytopathology & histopathology

MHRA reference: 2019/003/019/487/008

Marquardt: Staple 1.0mm 90degree

13 March 2019

Osteosynthesis, skeletal pins, wires & staples

MHRA reference:2019/002/005/401/012

Medtronic: Conexus Telemetry - Security Bulletin

21 March 2019

Implants, active, cardiac programmers and remote monitoring

Model: Conexus Telemetry and Monitoring Accessories used with Medtronic ICD, CRT-D, Programmers and

Remote Monitoring - Security Bulletin

MHRA reference: 2019/003/025/487/007

Mikrogen: recomLine Helicobacter 2.0 IgG/IgA

13 March 2019

IVDs, immunology

MHRA reference: 2019/003/019/487/007

Network Medical Products: Coronet

CAPA 216

Surgical instruments, articulated cutting

Model: 51-835-7.50

MHRA reference: 2019/003/015/601/006

Philips: MultiDiagnost Eleva with Flat Detector, Allura Xper systems and Allura Centron

19 February 2019

X Ray, fluoroscopy systems

708037, 708038

722001, 722003, 722005, 722006, 722008,722010, 722011, 722012, 722013, 722014, 722015, 722020, 722023, 722026, 722027, 722028, 722029, 722031, 722035, 722038, 722039, 722058 and 722400.

MHRA reference: 2019/003/005/487/001

Roche: ALBP - Albumin BCP

March 2019

IVDs, clinical chemistry

MHRA reference: 2019/003/006/487/004

Siemens: Syngo Via

04 March 2019

Computed tomography

10496180 - 10561669 and 10561495

MHRA reference: 2019/003/019/601/008

Siemens: ARTISTE; ONCOR; PRIMUS

TH001-19-S

Radiotherapy

08139789; 05863472; 05857912; 07360717; 05857920; 04504200; 01940035; 05500371

MHRA reference: 2019/003/020/601/011

Thermo Fisher: Oxoid CM1106B

20 March 2019

IVDs, bacteriology

MHRA reference: 2019/003/020/601/007

Thermo Fisher Scientific: Oxoid

12 March 2019

IVDs, bacteriology

Model: PO1186A

MHRA reference: 2019/003/013/601/015

Tosoh Corporation: ST AIA-PACK Homocysteine

19 March 2019

IVDs, clinical chemistry

MHRA reference: 2019/003/018/291/011

WEINMANN Emergency Medical Technology

18 February 2019

Lung ventilators

MEDUMAT Transport (WM 28415 und 28315)

MEDUMAT Standard a (WM 22810)

MEDUMAT Standard (WM 22510)

MODUL Oxygen (WM 22175)

MODUL Combi (WM 22177)

ULMER Koffer Verband (WM 8715)

ULMER Koffer Basis (WM8635)

ULMER Koffer Baby (WM 3693)

ULMER Koffer Kreislauf (WM 5225)

MHRA reference: 2019/003/019/291/003

Updates to this page

Published 25 March 2019