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