Field Safety Notice - 29 January - 2 February 2018
Summary List of field safety notices (FSNs) from medical device manufacturers from 29 January to 2 February 2018
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
View the latest FSNs
Beckman Coulter: COULTER EPICS Series Flow Cytometers
17 January 2018
IVDs, haematology
MHRA reference: 2018/001/025/601/005
BIOMERIEUX: Etest® Polymyxin B PO 0.064-1024 B30
29 January 2018
IVDs, bacteriology
MHRA reference: 2018/001/030/000/003
Biomet: ACE Trochanteric Nail (ATN) System
31 January 2018
Osteosynthesis, nails intramedullary
Model: ACE Trochanteric Nail (ATN) System
MHRA reference: 2018/002/001/000/009
GB UK (Enteral): CAREFEED FEEDING AND DRAINAGE TUBE
24 January 2018
Feeding systems and tubes
Model: CAREFEED FEEDING AND DRAINAGE TUBE CF01.14.092ISOSAF
MHRA reference: 2018/001/026/701/019
GE: CARESCAPE Central Station
FMI 36124
Monitors, patient
Model: Carescape central unit
MHRA reference: 2018/001/024/228/006
IM Services B.V.: Semen collection container 125 ml with label
January 2018
Laboratory equipment associated with IVF, cells, tissues
MHRA reference: 2018/001/025/000/005
Implantcast GmbH: 2M insert 15° for MUTARS® RS cup and LUMiC® TiN
28 December 2017
Joint prosthesis, hip
Model: 02423839; 02424244; 02424448; 02424652
MHRA reference: 2017/012/001/291/032
MAKO Surgical Corp (Stryker): MAKO RIO Spare Part Ethernet-Fiber Optic Converter
January 2018
Surgical navigation system
MHRA reference: 2018/001/025/701/013
Medistim ASA: VeriQ, MiraQ
18 January 2018
Ultrasound, imaging
MHRA reference: 2018/001/015/291/001
Medtronic: BI70000028230 O-arm® 1000 Surgical Imaging System (3rd edition)
January 2018
X Ray, fluoroscopy systems
MHRA reference: 2018/001/031/000/022
OCULUS Optikgeräte: Pentacam AXL
15 November 2017
Optical, ophthalmic instruments & equipment
Model: 70100
MHRA reference: 2018/001/012/291/001
Orthofix: DOUBLE ROW FOOTPLATES, TL-HEX STERILE, ALL SIZES
23 January 2018
Osteosynthesis, external fixators
MHRA reference: 2018/001/026/000/018
Pacific Medico:PMH 7000 Series
19 January 2018
Breathing system components
Model: PMH 7000 Series
MHRA reference: 2018/002/001/291/011
Philips: IQon Spectral CT
11 January 2018
Computed tomography
Model: 728332
MHRA reference: 2018/001/025/000/002
Philips: CPR Meter w/Q-CPR® Technology
19 January 2018
Defibrillators, non-implantable
Model: 861444, 861332, 861322, 989803139951, 989803162401, 989803149941
MHRA reference: 2018/001/029/000/014
Philips: Avent smart ear thermometer and ear thermometer
26 January 2018
Diagnostic measurement and monitoring
Model: SCH740 and DL8740
MHRA reference: 2018/001/029/000/009
RaySearch Laboratories: RayStation
26 January 2018
Radiotherapy planning and verification systems
Model: RayStation 4.9 (RayPlan 1), RayStation 5, RayStation 6 (RayPlan 2) and RayStation 7 (RayPlan 7)
MHRA reference: 2018/002/001/000/008
Siemens: ARTIS one
12 December 2017
X ray, fluoroscopy systems
Model: 10848600
MHRA reference: 2018/001/030/601/004
Smiths Medical: CADD® Medication Cassette Reservoir
January 2018
Infusion systems
Model: 21-7001-24; 21-7002-24; 21-7100-24
MHRA reference: 2017/010/012/701/035