Field safety notices - 5 to 9 October 2015
List of field safety notices (FSNs) from medical device manufacturers from 5 to 9 October 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
Ansell Healthcare Europe: Gammex PF
October 2015
Gloves, surgical and examination
MHRA reference: 2015/009/022/292/014
Armstrong Medical: AquaVent neo neonatal heated CPAP
7 October 2015
Humidifiers
Model: System REF. AMCP 1409/031
MHRA reference: 2015/009/011/291/009
Arrow International Inc: pressure injectable peripherally inserted central catheter (PICC) – 4FR
28 September 2015
Vascular cannula and catheters
Model: Arrow select kits, Arrow pressure injectable PICC kit with Blue, FlexTip, Arrow pressure injectable PICC kit with Blue FlexTip catheter, Arrow pressure injectable PICC set with Blue FlexTip catheter, EU Arrow select kits, EU special order product
MHRA reference: 2015/009/029/081/002
Bio-Rad: urinary metanephrines by HPLC (195-5411, 195-5412)
8 October 2015
IVDs, clinical chemistry
MHRA reference: 2015/010/008/292/006
Depuy Synthes: chronOS Inject bone void filler
2 October 2015
Implant materials, bone substitutes
MHRA reference: 2015/010/007/071/004
Ethicon Endo-Surgery: Harmonic ACE+7, 5 mm diameter shears, 23 cm length with advanced hemostasis
5 October 2015
Surgical power tools
Model: HARH23, HARH36, HARH45
MHRA reference: 2015/010/005/292/009
Flexicare Medical: T-piece 22mm male/ female
6 October 2015
Resuscitators
Model: 010-631
MHRA reference: 2015/009/011/292/004
GE Healthcare: Centricity PACS-IW
FMI 85410
Picture archiving and communication system (PACS)
Model: Centricity PACS-IW versions 3.5.0 through 3.7.3.9 SP2, 3.7.3 SPA10 and 4.0.1
MHRA reference: 2015/010/005/292/012
GE Healthcare: universal viewer
FMI 85413
Picture archiving and communication system (PACS
Model: Centricity PACS-IW with universal viewer versions 5.0 SP2 and higher and Centricity universal viewer versions 6.0 and higher
MHRA reference: 2015/010/006/292/012
Intelerad Medical: IntelePACS
September 2015
Picture archiving and communication system (PACS)
Model: versions 4.5.1 and up
MHRA reference: 2015/009/018/601/010
Intuitive Surgical: · da Vinci Si single-site grip release15
14 September 2015
Endoscopes, rigid
Model : 428050-12, -13, -14; · 428053-12, -15;· 428055-12, -13;· 428056-12, -13;· 428058-12, -13;· 428059-12, -13;· 428080-04, -05;· 428088-12, -13;· 428093-12, -13
MHRA reference: 2015/009/015/081/005
JenaValve Technology GmbH: The JenaValve
CC15-005
Implants, non-active, cardiovascular heart
MHRA reference: 2015/010/006/299/005
Johnson & Johnson: PowerStar bipolar cable
30 September 2015
Surgical, diathermy
MHRA reference: 2015/010/007/701/007
Mercury Medical: T-piece neonatal patient circuit kit
1 October 2015
Breathing system components
Model: M1091335VS
MHRA reference: 2015/010/002/291/030
Philips Healthcare: HeartStart defibrillator/monitor
October 2015
Defibrillators, non-implantable
Model: MRx
MHRA reference: 2015/005/022/401/019
Philips Medical: Brilliance 16-slice (Air) Brilliance 64 CT, Ingenuity Core, Ingenuity Core128, Brilliance CT Big Bore, Ingenuity Flex
FCO72800635
Computed tomography
Model: 728246 – Brilliance 16-Slice (Air), 728231 – Brilliance 64 CT, 728321 – Ingenuity Core, 728323 – Ingenuity Core128, 728243/728244 – Brilliance CT Big Bore, 728317 - Ingenuity Flex
MHRA reference: 2015/010/006/292/010
Roche Diagnostics: cobas p 612 pre-analytical system
30 September 2015
IVDs, clinical chemistry
Model: 05082579001
MHRA reference: 2015/010/002/701/010
Siemens Healthcare Diagnostics Products: Enzygnost anti-VZV / IgG
October 2015
IVDs, viral microbiology
Model: OWLT15
MHRA reference: 2015/010/005/299/003
Stryker: Exeter small and large tapered pin reamer
September 2015
Surgical instruments, implant
Model: 932-0-000 and 0932-2-000
MHRA reference: 2015/009/023/292/022
Varian Medical Systems: ARIA radiation oncology
29 September 2015
Radiotherapy planning and verification systems
MHRA reference: 2015/010/005/701/002