Field Safety Notice - 05 November to 09 November
List of field safety notices (FSNs) from medical device manufacturers from 05 November to 09 November
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
Abiomed: Impella 2.5 Herzpumpe, Impella CP Herzpumpe
20 September 2018
Cardiac assist pumps
Model: 0046-3061, 0048-3075, 0048-0010, 0048-0008
MHRA reference: 2018/011/006/291/004
Ad-Tech Medical Instrument: Drill Sleeve Guide
02 May 2018
Surgical power tools
MHRA reference: 2018/011/001/601/004
Allurion Technologies: Elipse Filler Kit
0066
Implants, non active, gastrointestinal
Model: 11A
MHRA reference: 2018/011/007/291/012
Boston Scientific: Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) system's SQ-RX™ Model 1010 Pulse Generator (PG)
November 2018
Implants, active, defibrillators
Model: SQ-RX™ Model 1010
MHRA reference: 2018/011/006/487/005
CellPath: CLARITEX WHITECOAT SLIDE
15 October 2018
IVDs, cytopathology & histopathology
MHRA reference: 2018/011/008/701/031
Changzhou: Disposable skin stapler
01 November 2018
Staples and staple guns
MHRA reference: 2018/011/005/291/008
Eurotrol: Eurotrol Hemoglobin Controls
22 October 2018
IVDs, haematology
MHRA reference: 2018/010/030/701/009
GE: Giraffe Omnibed and Giraffe Incubator; Giraffe Warmer, Panda iRes Warmer
FMI 332064
Infant incubators
MHRA reference: 2018/011/006/291/010
GE: Aisys, Aisys CS2
FMI 34094
Anaesthetic machines & monitors
MHRA reference: 2018/011/006/291/014
Mediplus
09 November 2018
Injection devices
MHRA reference: 2018/011/008/601/003
Medtronic: Medtronic StrataMR Adjustment Tool Kit
November 2018
Implants, non active, hydrocephalus shunts
Model: 45905
MHRA reference: 2018/011/008/291/008
Novacor: R.Test Evolution 4
12 October 2018
ECG
MHRA reference: 2018/011/006/291/007
Ortho-Clinical: VITROS: Folate, FreePSA, FSH, Prolactin & TSH
November 2018
IVDs, clinical chemistry 1513266, 6842845, 1931922, 1849793, 1912997
MHRA reference: 2018/007/023/601/001
Southmedic: Uresta Bladder Support
05 November 2018
Implants, non-active, implantable incontinence and prolapse devices UR202, UR202-EU, UR203, UR204, UR205, UR206, UR206-EU
MHRA reference: 2018/011/007/291/002
Thermo Fisher: Oxoid Brilliance VRE Agar
08 November 2018
IVDs, bacteriology
MHRA reference: 2018/011/008/601/012
Zimmer: Various Trauma Guide Wires
06 November 2018
Orthopaedic surgical instruments - measuring tools
MHRA reference: 2018/011/007/291/017