Field Safety Notices - 6 February - 10 February 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 6 February - 10 February 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
Bausch + Lomb: LazerEdge Knifes
18 October 2016
Surgical instruments, non-articulated cutting
MHRA reference:
Boston Scientific: AngioJet庐 Ultra 5000A Console Foot Switch
7 February 2017
Vascular cannula and catheters
MHRA reference:
Carl Zeiss Meditec: CT ASPHINA
1 February 2017
Implants, non-active, intraocular
Model: 409MP 20.0D
MHRA reference:
Clinical Innovations: Kiwi Omni Vacuum Delivery System
16 January 2017
Surgical equipment, miscellaneous
Model: VAC-6000M
MHRA reference:
Cook Medical: Flexor Radial Access Set
06 February 2017
Vascular cannula and catheters
MHRA reference:
Covidien: Valleylab鈩� Laparoscopic Handset Four-Function
2 February 2017
Surgical, diathermy
Model: Valleylab
MHRA reference:
Greatbatch Medical: Standard Offset Cup Impactor
3004976965-07/28/2016-003-C
Orthopaedic surgical instruments - impacting tools
Model: T15949, T17238; T9954; T9955; T8468; T11506; T10281; T8044; T17203; T8177; T16934; T11340; T8043; T17321; T15311; T17650; T8143; T14384; T16661; T9316; T13642; T10753; T9348; T13480; T10243; T11209; T10861; T16427; T9894; T12861; T8088; T16611; T9360; T13344; T13722; T7821; T10287; T8042; T17703; T6318; T8333; T9747; T8487; T8184; T9196; T12699
MHRA reference:
Hospira: Plum 360 Infusion pump
30 January 2017
Infusion systems
Model: Plum 360 (30010)
MHRA reference:
John Reid & Sons (Structsteel): Orthopaedic Leg Trolley
29 November 2016
Walking aids, walking frames
Model: K9
MHRA reference:
Olympus: Video telescope "ENDOEYE HD II", 10 mm, 0掳 and 30掳
3 February 2017
Endoscopes, rigid
Model: WA50040A (0掳), WA50042A (30掳)
MHRA reference:
Philips: Philips Efficia CMS200 Central Monitoring System
December 2016
Monitors, patient
Model: 863352 (CMS200)
MHRA reference:
Roche: See below under "Accessories"
31 January 2017
IVDs, viral microbiology
Model: cobas 庐 HIV-1 Test for use on the cobas 庐4800 system (Cat. No. 06979599190) GMDN Code: 30768 Nomenclature Text: HIV1 nucleic acid IVD, kit, nucleic acid technique (NAT) - cobas庐 HBV Test for use on the cobas 庐 4800 system (Cat. No.06979564190) GMDN Code: 48307
MHRA reference:
Roche Diagnostics: TSH
03 February 2017
IVDs, clinical chemistry
Model: 11731459122
MHRA reference:
Samsung: Ultrasound
FSCA-WS80A-161122003
Ultrasound, imaging
Model: WS80A
MHRA reference:
Siemens: ADVIA Centaur XPT
February 2017
IVDs, clinical chemistry
MHRA reference:
Siemens: Radiotherapy
TH008/16/S
Radiotherapy
Model: Mevatron (Artiste), Primus, Oncor
MHRA reference:
Siemens: Axiom Artis
24 January 2017
X-ray, fluoroscopy systems
MHRA reference:
Siemens: ADVIA 560 Hematology System
December 2016
IVDs, haematology
Model: SMN 11170842
MHRA reference: