Field safety notices - 5 to 8 May 2015
List of field safety notices (FSNs) from medical device manufacturers from 5 to 8 May 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
View the latest FSNs
Res Med: Adaptive Servo-Ventilation (ASV) Therapy
May 2015
MHRA reference: 2015/005/012/291/008.
Advanced Neuromodulation: Eon Wall charger and Eon Portable Charger
29 April 2015
Implants, Active, Stimulators, Neuro
Model: 3701, 3711
MHRA reference: 2015/004/030/701/006
Baxter Healthcare: CE INFUSOR Patient Control Module Watch (PCM), 0.5 mL
May 2015
Infusion Systems
Model: CE INFUSOR Patient Control Module Watch (PCM), 0.5 mL
MHRA reference: 2015/005/006/291/006
Covidien: Palindrome™ Precision SI Chronic Catheter, Palindrome™ SI Chronic Catheter,Palindrome™ Precision HSI Chronic
Catheter, and Palindrome™ HSI Chronic Catheter
May 2015
Vascular Cannula and Catheters
MHRA reference: 2015/005/005/701/005
Covidien: VenaSeal Closure System
30 April 2015
Implants, Non Active, Vascular Haemostasis Device
Model: Model SP-101
MHRA reference: 2015/005/001/291/004
GE Healthcare: Centricity PACS IW
FMI 85384
Picture Archiving And Communication System
Model: GE Centricity PACS IW versions
MHRA reference: 2015/005/005/291/018
Life Technologies: AllSet+ Gold and UniTray
13 April 2015
IVDs, Immunology
Model: AllSet+ Gold and UniTray
MHRA reference: 2015/004/030/601/011
Medline: security information of Devon™ flexible light handle cover
FSCA 15 – 01
Surgical devices, non-powered
Model: Custom specific sets manufactured by Medline Int.
MHRA reference: 2015/005/005/291/026
Medtronic 3F Therapeutics: 3f Enable™ Aortic Bioprosthesis
May 2015
Implants, Non Active, Cardiovascular Heart Valves
Model: 6000
MHRA reference: 2014/011/020/081/002
Orthofix: Galaxy Unyco Diaphyseal tibia sterile kit
04 May 2015
Surgical Instruments, Implant
Model: 99-93506
MHRA reference: 2015/005/005/701/004
Philips Medical Systems: DigitalDiagnost
26 March 2015
X Ray, Digital Acquisition Systems
Model: DigitalDiagnost 712027, 712028, 712029
MHRA reference: 2015/005/005/291/009
Philips Healthcare: Philips IntelliVue Information Center iX
07 April 2015
Monitors, Patient
Model: Philips IntelliVue Information Center iX 866389 options LAB or 30N or 30S or 30U or 35N or AB3
MHRA reference: 2015/005/005/291/008
Philips Healthcare: DuraDiagnost 3.0/4.0
15 April 2015
Direct Digital Radiography
Model: 712211, 712214
MHRA reference: 2015/005/005/291/031
Remel Inc: PathoDX Strep Grouping
28 April 2015
IVDs, Bacteriology
Model: PathoDX Strep Grouping (R62031 / R62025)
MHRA reference: 2015/004/030/601/009
Stephanix: D2RS / DX-D800 / Xcellence Dynamic
D2RS 20150331
Imaging, Patient Support
Model: D2RS / DX-D800 / Xcellence Dynamic
MHRA reference: 2015/005/005/291/029
Terumo Europe: Terumo® Radifocus Guide Wire M
FSN 1502 2015-05
Vascular Cannula/Catheter Accessories
Model: Terumo® Radifocus Guide Wire M
MHRA reference: 2015/005/005/291/032
The Learning Clinic Limited: VitalPAC
April 2015
Diagnostic Measurement and Monitoring
Model: v2.3, v3.0
MHRA reference: 2015/004/020/601/007