Field Safety Notice - 24 April to 28 April 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 24 - 28 April 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
AMO Uppsala: Healon, Healon GV, Healon 5 Pro, Healon Pro
April 2017
Implants, non active, intraocular
Model: 10200011, 10200012, 10200014, 10201012, 10201014, 10202014, 10270012, 10270015
MHRA reference: 2017/004/020/701/018
Autonomic Technologies: Pulsante SPG Microstimulator System
07 April 2017
Implants, active, leads, neuro
Model: NS-100, RC-200, SI-100-E, SI-110-E, SI-120-E, LB-100-E, PS-100
MHRA reference: 2017/004/004/299/008
Beckman Coulter: Access BR Monitor
18 April 2017
IVDs, clinical chemistry
Model: Not Applicable
MHRA reference: 2017/004/020/601/009
Beckman Coulter: Synchron Systems Cholesterol, Creatinine, HDL Cholesterol, Lactate, Triglyceride, Uric Acid and Salicylate Reagents
18 April 2017 - FA-29156
IVDs, clinical chemistry
MHRA reference: 2017/004/020/601/007
Carl Zeiss: VisuMax with Treatment-Pack and accessories
23 January 2017
Therapy, lasers
Model: VisuMax with Treatment-Pack and accessories
MHRA reference: 2017/004/025/299/027
Cook Medical: See Comments Section
2017FA0005
Sutures
Model: Pereyra-Raz Ligature Carrier™ Pereyra Ligature Carrier '75® Stamey Needle
MHRA reference: 2017/004/027/701/009
Cook Medical: Stamey Needle
24 April 2017
Sutures
MHRA reference: 2017/004/026/701/006
Medical Intelligence Medizintechnik:
FCA-MI-0001
Radiotherapy
Model: Intelligence Mediz
MHRA reference: 2017/004/027/701/020
One Lambda: LABScreen® Multi
19 April 2017
IVDs, immunology
MHRA reference: 2017/004/021/701/015
Ortho Solutions: OXFORD/ OXBRIDGE AFN END CAP 10mm x 5mm to 12mm x 10mm
19 April 2017
Osteosynthesis, nails intramedullary
Model: OS331100-07
MHRA reference: 2017/004/021/601/009
PEROUSE MEDICAL: Dolphin Inflation Device/Caliber Inflation Device
FSCA-PM-2017-01
Vascular cannula/catheter accessories
MHRA reference: 2017/004/025/701/012
Randox Laboratories: Liquid Urine Control - Level 3
20 April 2017
IVDs, clinical chemistry
Model: UC5075, Liquid Urine Control - Level 3
MHRA reference: 2017/004/026/601/012
Spacelabs: 99999, Arkon Anesthesia Delivery System
13 April 2017
Anaesthetic machines & monitors
MHRA reference: 2017/004/025/701/014
Siemens: ADVIA Centaur Insulin
CC 17-10
IVDs, clinical chemistry
Model: SMN 10310439 SMN 10310438
MHRA reference: 2017/004/010/601/005
Stryker: Exeter V40 Femoral Stems (44mm, No. 0, L. 150mm)
RA2017-011
Joint prosthesis, hip
Model: Exeter
MHRA reference: 2017/004/021/701/006
bioMérieux: VITEK® 2 Identification / Antimicrobial Susceptibility Test Cards referenced in Appendix A
20 April 2017
IVDs, bacteriology
MHRA reference: 2017/004/025/291/012