Field safety notices - 5 to 8 May 2015

List of field safety notices (FSNs) from medical device manufacturers from 5 to 8 May 2015.


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

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