Field Safety Notices: 19 to 23 September 2022
Summary List of field safety notices (FSNs) from medical device manufacturers from `9 to 23 September 2022.
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 a list of FSNs published since January 2020
View FSNs since November 2014. FSNs before this date are on the National Archives website
Acumed: 2.7mm x 14mm Locking Hexalobe Screw
15 September 2022
Osteosynthesis, Bone Screws
MHRA reference: 2022/009/016/601/500
Acumed: 2.7mm x 16mm Locking Hexalobe Screw
R22-004
Osteosynthesis, Bone Screws
MHRA reference: 2022/009/016/601/501
Boston Scientific: 41M402, 41M401, 61M401 FARAWAVE - FARASTAR - FARAPULSE SYSTEM Brand
15 September 2022
Therapy Tissue Ablation
MHRA reference: 2022/009/020/611/008
HufriedyGroup: K360 Scalpel Handle
30 August 2022
Surgical Instruments, Non Articulated
MHRA reference: 2022/008/026/596/012
Leica Biosystems: Formula R Paraffin
04 August 2022
IVDs, Cytopathology & Histopathology
MHRA reference: 2022/009/021/596/001
Löwenstein Medical: elisa 600, elisa 800 und elisa 800 vit
02 September 2022
Lung Ventilators
MHRA reference: 2022/009/016/611/006
Nipro Medical Europe: SURDIAL
09 September 2022
Dialysis, Haemodialysis
MHRA reference: 2022/009/015/601/003
Philips: SyncVision System
2021-IGT-IGTD-002
X Ray, Fluoroscopy Systems
MHRA reference: 2022/009/016/601/001
Philips: Amara View Minimal Contact Full-Face Mask (Full Face Mask)
DreamWear Full Face Mask (Full Face Mask)
DreamWisp Nasal Mask with Over the Nose Cushion (Nasal Mask)
Wisp Nasal Mask (Nasal Mask)
Wisp Youth Nasal Mask (Nasal Mask)
Therapy Mask 3100 NC/SP (Nasal Mask)
29 August 2022
Anaesthetic & Breathing, Masks
MHRA reference: 2022/008/015/596/001
The above FSN is comprised of 3 parts:
- 2022/008/015/596/001 - FSN a - for Distributors/ Prescribers
- 2022/008/015/596/001 - FSN b - for Patients
- 2022/008/015/596/001 - FAQs - as referenced within the FSN
Roche: cobas 5800 Instrument 08707464001
SBN-RDS-Molecular Lab-2022-005
IVDs, Clinical Chemistry
MHRA reference: 2022/009/013/701/060
Siemens Healthineers: CLINITEK Novus PRO 12 Urinalysis Cassette
September 2022
IVDs, Clinical Chemistry
MHRA reference: 2022/009/015/601/002
ThermoFisher Scientific: CM0301W/B/T/R Thermo Scientific
10 September 2022
IVDs, Bacteriology
MHRA reference: 2022/009/013/601/506