Field safety notices - 29 June to 3 July 2015
List of field safety notices (FSNs) from medical device manufacturers from 29 June to 3 July 2015.
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
Animas Corporation
29 May 2015
Infusion systems
Model: Animas insulin pumps
MHRA reference: 2012/010/019/081/023
Baxter Healthcare: Flo Gard 6201 compatible blood set
June 2015
Infusion and transfusion, administration sets
MHRA reference: 2015/006/029/291/010
Biosense Webster: NMARQ circular irrigated catheter
24 June 2015
Therapy, tissue ablation
MHRA reference: 2015/006/022/291/017
Ecolab: Sterile 60ml EU BD syringe multi-packs
12 June 2015
Injection devices
Model: 3058460
MHRA reference: 2015/006/016/291/003
GE Medical Systems LLC: Precision 500D - Advantx Legacy/Legacy-D
FMI 10902
X-Ray, fluoroscopy systems
MHRA reference: 2015/007/001/291/005
Hoffrichter: Hoffrichter Trend II, point, Vector et
30 June 2015
Lung ventilators
Model: Home CPAP unit
MHRA reference: 2015/006/002/291/007
Maquet Cardiopulmonary AG: heater cooler unit HCU 40 high voltage
23 June 2015
Infusion and transfusion, heart lung circuits
Model: 70104.4054
MHRA reference: 2015/006/026/051/004
Medline Industries: charging base for surgical clipper
June 2015
Surgical equipment, miscellaneous
MHRA reference: 2015/006/025/291/006
Medical Components: MEDCOMP HEMO-CATH LT and HEMO-CATH ST; JET Flow
12 June 2015
Vascular cannula and catheters
Model: See P.S.A. June 12 Medcomp; Jet –Medical
MHRA reference: 2015/007/001/291/002
St Jude Medical: Nanostim™ leadless pacemaker
02 July 2015
Implants, active, pacemakers
Model: S1DLCP
MHRA reference: 2015/002/020/131/004
TORNIER: Aequalis IM nail targeting jig
29 June 2015
Surgical instruments, implant
MHRA reference: 2015/006/030/291/001
Roche Diagnostics: cobas b 123 POC systems
23 June 2015
IVDs, extra laboratory testing
Model: blood gas analyser
MHRA reference: 2015/007/001/701/004
Volcano: S5 and Core family with SW version 3.3/3.4
30 June 2015
Ultrasound, imaging
MHRA reference: 2015/007/001/291/003
Zethon: Forceps
03 July 2015
Surgical, diathermy
MHRA reference: 2015/006/030/291/002
Zimmer Biomet UK: AGC dual articular 2000 knee femoral component
29 June 2015
Joint prosthesis, knee
MHRA reference: 2015/007/001/291/018