Field safety notices - 18 to 22 January 2016
List of field safety notices (FSNs) from medical device manufacturers from 18 January to 22 January 2016.
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
Baxter: Uromatic Tur admin set
January 2016
Infusion & transfusion, administration sets
MHRA reference: 2016/001/019/292/013
Baxter Healthcare SA: HomeChoice automated PD system and HomeChoice PRO automated PD system
January 2016
Dialysis, peritoneal
Model: R5C8320, 5C4474, 5C4471 and 5C8310
MHRA reference: 2016/001/015/292/007
GE Healthcare: Anaesthesia system
FMI34071
Anaesthetic machines & monitors
Model: Aespire 7900 Aespire View Aestiva 7900 Aestiva MRI Aisys Aisys CS2 Amingo & AvanceAvance CS2
MHRA reference: 2016/001/015/292/001
GE Healthcare: PRN 50-M+ digital writer
FMI36116
Radiotherapy
Model: Model 600‐23310‐10, GE part number 2062759-001
MHRA reference: 2016/001/019/292/019
GE Medical Systems: Optima XR220amx, Optima XR200amx, Brivo XR285amx
GEHC Ref 10906
X-ray, digital acquisition systems
MHRA reference: 2016/001/004/292/008
Immucor: Capture-R® Ready-ID®; Panocell-20®; Panocell-16®
18 January 2016
IVDs, Blood Transfusion
MHRA reference: 2016/001/019/292/009
Leica Biosystems Newcastle: Bond™ polymer Refine detection kit and Novolink™polymer detection systems
6 January 2016
IVDs, cytopathology & histopathology
Model: DS9800 and RE7280
MHRA reference: 2016/001/007/601/009
Leica Microsystems: surgical microscope
19 January 2016
Surgical equipment, miscellaneous
Model: various models
MHRA reference: 2016/001/021/292/033
Natus Medical Incorporated DBA Excel-Tech: Quantum amplifier
9612330-11/16/2015/001-C
Monitors, patient
Model: Quantum
MHRA reference: 2015/012/015/291/009
Siemens Healthcare: ADVIA Centaur Enhanced Estradiol; Dimension Vista LOCI Estradiol; IMMULITE/IMMULITE 1000 Estradiol; IMMULITE 2000 Estradiol
January 2016
IVDs, clinical chemistry
MHRA reference: 2016/001/018/601/005
Smith & Nephew: LEGION screw-on hemi stepped tibial wedge
18 January 2016
Joint prosthesis, knee
MHRA reference: 2016/001/020/292/004
Varian: Eclipse™ treatment planning system H48
11 January 2016
Radiotherapy planning and verification systems
MHRA reference: 2016/001/019/701/002