Field Safety Notice - 10 to 14 July 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 3 to 7 July 2017
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
Acumed: Acumed Kickstand Post; 2.8mm Locking Drill Guide
27 June 2017
Orthopaedic surgical instruments - Insertion/extraction tools
Model: Kickstand Post: 80-0718; 80-0720; 80-0722; 80-0731
MHRA reference: 2017/007/010/291/030
CellPath: General Histology Instruments
01.139.546 FSCA
IVDs, viral microbiology
MHRA reference: 2017/007/012/291/006
Depuy Synthes: Transpedicular Schanz Screws
6 June 2017
Osteosynthesis, bone screws
Model: Transpedicular Schanz Screws
MHRA reference: 2017/005/025/291/009
Heartway Medical: Minimo Plus 4 S19F
23 June 2017
Scooters, powered
MHRA reference: 2017/006/027/291/003
Hologic: Affirm Lateral Arm Biopsy Accessory Kit
14 July 2017
Surgical instruments, minimal access
Model: ASY-098880
MHRA reference: 2017/007/013/601/001
Leica Biosystems: ASP6025
June 2017
IVDs, cytopathology & histopathology
MHRA reference: 2017/006/012/291/029
Medtronic: Spinous Process Clamp Tall and Short (Model 9734715 and 9734716), Double Spinous Process Clamp Tall and Short (Model9734723 and 9734724)
11 July 2017
Surgical instruments, articulated holding
Model: 9734715, 9734716, 9734723, 9734724
MHRA reference: 2017/007/011/291/025
Pulsar Vascular: PulseRider®
11 July 2017
Implants, non-active, embolisation
MHRA reference: 2017/007/003/701/001
Siemens: ADVIA Chemistry Assays, Dimension Assays, Dimension Vista Assays, Syva Assays
June 2017
IVDs, clinical chemistry
MHRA reference: 2017/007/013/601/003
SHIMADZU Corporation: RADspeed Series (Pro/CH-200/CH-200M)
26 May 2017
X Ray, general
MHRA reference: 2017/006/029/701/007