Field Safety Notices - 20 to 24 April 2020

Summary list of field safety notices (FSNs) from medical device manufacturers from 20 to 24 April 2020

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 NV: DR 800

VR0000728

X ray, fluoroscopy systems

MHRA reference: 2020/004/001/291/006

Apyx Medical Corporation: Renuvion/J-Plasma Precise & Precise Open Handpiece

23 April 2020

Surgical, diathermy

MHRA reference: 2020/004/021/701/030

Bentley InnoMed: BeGraft Coronary Stent Graft System

22 April 2020

Implants, non active, coronary stents

MHRA reference: 2020/004/022/487/007

Biomet: Comprehensive SRS/Discovery

23 April 2020

Joint prosthesis, elbow

MHRA reference: 2020/004/023/487/008

GE Healthcare: Giraffe Shuttle

FMI 32075

Infant incubators

MHRA reference: 2020/004/023/291/004

Mast Group: MAST DICS ID

16 April 2020

IVDs, bacteriology

Model: D45C

MHRA reference: 2020/004/017/601/003

Medtronic: Verify Evaluation Clinician Software Application, Verify Evaluation Patient Software Application

April 2020

Implantable neuro stimulators

Model: A511, A521

MHRA reference: 2020/004/022/487/006

Philips Health Systems: Sterilizable Defibrillator Internal Paddles

6 April 2020

Defibrillators, non implantable

Model: M1741A, M1742A, M1743A, M1744A, M4741A, M4742A, M4743A, M4744A

MHRA reference: 2020/004/023/291/002

Philips Healthcare: HeartStart XL Defibrillator/Monitor

10 April 2020

Defibrillators, non implantable

Model: M4735A

MHRA reference: 2020/004/023/291/006

Philips Healthcare Inc: HeartStart MRx Defibrillator/Monitor

10 April 2020

Defibrillators, non implantable

Model: M3535A, M3536A and M3536M

MHRA reference: 2020/004/023/291/007

Philips Medical Systems: Pneumograph, chest, NM, 3160

March 2020

Magnetic resonance, equipment & accessories

Model: 94023

MHRA reference: 2020/004/021/487/008

Roche: cobas® 6500 urine analyzer series (cobas u 701 microscopy analyzer in combination with cobas u 601 urine analyzer)

April 2020

IVDs, clinical chemistry

MHRA reference: 2020/004/015/487/010

Roche Diagnostics GmbH: Accu-Chek® Aviva test strips

SB_RDC_2019_08

IVDs, self / home testing

MHRA reference: 2020/003/027/291/001

Valoc AG: Adapter Optiloc for handpiece, length 26mm

16 April 2020

Dental appliances / instruments

MHRA reference: 2020/004/020/291/001

Published 27 April 2020