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
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Agfa HealthCare NV: DR 800
VR0000728
X ray, fluoroscopy systems
MHRA reference:
Apyx Medical Corporation: Renuvion/J-Plasma Precise & Precise Open Handpiece
23 April 2020
Surgical, diathermy
MHRA reference:
Bentley InnoMed: BeGraft Coronary Stent Graft System
22 April 2020
Implants, non active, coronary stents
MHRA reference:
Biomet: Comprehensive SRS/Discovery
23 April 2020
Joint prosthesis, elbow
MHRA reference:
GE Healthcare: Giraffe Shuttle
FMI 32075
Infant incubators
MHRA reference:
Mast Group: MAST DICS ID
16 April 2020
IVDs, bacteriology
Model: D45C
MHRA reference:
Medtronic: Verify Evaluation Clinician Software Application, Verify Evaluation Patient Software Application
April 2020
Implantable neuro stimulators
Model: A511, A521
MHRA reference:
Philips Health Systems: Sterilizable Defibrillator Internal Paddles
6 April 2020
Defibrillators, non implantable
Model: M1741A, M1742A, M1743A, M1744A, M4741A, M4742A, M4743A, M4744A
MHRA reference:
Philips Healthcare: HeartStart XL Defibrillator/Monitor
10 April 2020
Defibrillators, non implantable
Model: M4735A
MHRA reference:
Philips Healthcare Inc: HeartStart MRx Defibrillator/Monitor
10 April 2020
Defibrillators, non implantable
Model: M3535A, M3536A and M3536M
MHRA reference:
Philips Medical Systems: Pneumograph, chest, NM, 3160
March 2020
Magnetic resonance, equipment & accessories
Model: 94023
MHRA reference:
Roche: cobas庐 6500 urine analyzer series (cobas u 701 microscopy analyzer in combination with cobas u 601 urine analyzer)
April 2020
IVDs, clinical chemistry
MHRA reference:
Roche Diagnostics GmbH: Accu-Chek庐 Aviva test strips
SB_RDC_2019_08
IVDs, self / home testing
MHRA reference:
Valoc AG: Adapter Optiloc for handpiece, length 26mm
16 April 2020
Dental appliances / instruments
MHRA reference: