Field safety notices - 09 to 13 July
Summary List of field safety notices (FSNs) from medical device manufacturers from 09 June to 13 July 2018.
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
BIOMERIEUX: BacT/ALERT VIRTUO Microbial Detection System
5 July 2018
IVDs, bacteriology
MHRA reference: 2018/007/005/291/041
Biomet (Zimmer Biomet): Persona® Spacer Block Alignment Tower
12 July 2018
Orthopaedic surgical instruments - insertion/extraction tools
MHRA reference: 2018/007/012/291/025
Cerner Corporation: Cerner Dosage Calculator
29 June 2018
Diagnostic / therapeutic software algorithm
MHRA reference: 2018/007/009/601/008
Convatec: AbViser AutoValve Pressure Monitoring Devic
25 April 2018
Urinary catheters and accessories
Model: ABV300; ABV301
MHRA reference: 2018/004/011/478/008
Cook Medical: Chorion Villus Biopsy Needle Set K-CVNS-1821-ROBINSON-ET
28 June 2018
Surgical instruments, minimal access
MHRA reference: 2018/007/006/701/005
DePuy Synthes: CORAIL® Cementless Femoral Stem HA coated
22 June 2018
Joint prosthesis, hip
Model: 3L92511, 3L92512
MHRA reference: 2018/007/012/291/006
DXC: iLab
5 July 2018
IVDs, clinical chemistry
Model: versions earlier than i.LAB TP AKI 2.0 Build 3_ER01
MHRA reference: 2018/007/006/601/003
EBR Systems: first generation WiSE CRT Model 4000 Transmitter
21 June 2018
Implants, active, pacemakers
MHRA reference: 2018/006/020/081/009
Etac: Molift 2-poing Sling Bar - all sizes
4 July 2018
Hoists and slings
Model: 1430016, 1430017, 1430021, 1830001, 183002, 183002C, 1830003
MHRA reference: 2018/007/006/701/009
Fritz Stephan: Sophie
01 June 2018
Lung ventilators
MHRA reference: 2018/007/012/291/001
GE Healthcare: Carescape Monitor B650
GEHC ref 36127
Monitors, patient
MHRA reference: 2018/007/003/291/031
Luminex: Brand
06 July 2018
IVDs, bacteriology
Model: JDK-2330 Rev B
MHRA reference: 2018/007/010/291/016
Megadyne (Update): MegaPower Electrosurgical Generator
July 2018
Surgical, diathermy
MHRA reference: 2018/005/030/701/005
Menarini Silicon Biosystems: CellSearch Circulating Tumor Cell Kit
12 April 2018
IVDs, cytopathology & histopathology
MHRA reference:2018/007/010/291/023
NordicNeuroLab: LCD Power Supply (LPS)
CPA-2018-473
Magnetic resonance, equipment & accessories
MHRA reference: 2018/007/009/291/033
Ortho Solutions: K-Wire
4 July 2018
Osteosynthesis, skeletal pins, wires & staples
Model: OS21675 & OS292120
MHRA reference: 2018/007/009/601/003
Philips: Brilliance 16 Air Brilliance 64 Brilliance iCT
3 July 2018
Computed tomography
Model: Brilliance 16 Air - 728246 Brilliance 64 – 728231 iCT – 728306
MHRA reference: 2018/007/010/291/015
Randox Laboratories: LIA3148 Custom Liquid Immunoassay Control Level 1
4 July 2018
IVDs, clinical chemistry
MHRA reference: 2018/007/005/601/003
Roche: Vitamin D total II assay
9 July 2018
IVDs, clinical chemistry
Model: Vitamin D total II assay on Elecsys and cobas e immunoassay analyzers
MHRA reference: 2018/004/018/701/015
Teleflex: Rusch Green Lite (MAC 3)
9 July 2018
Airway devices
MHRA reference: 2018/007/010/291/022