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
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Res Med: Adaptive Servo-Ventilation (ASV) Therapy
May 2015
MHRA reference: .
Advanced Neuromodulation: Eon Wall charger and Eon Portable Charger
29 April 2015
Implants, Active, Stimulators, Neuro
Model: 3701, 3711
MHRA reference:
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:
Covidien: Palindrome鈩� Precision SI Chronic Catheter, Palindrome鈩� SI Chronic Catheter,Palindrome鈩� Precision HSI Chronic
Catheter, and Palindrome鈩� HSI Chronic Catheter
May 2015
Vascular Cannula and Catheters
MHRA reference:
Covidien: VenaSeal Closure System
30 April 2015
Implants, Non Active, Vascular Haemostasis Device
Model: Model SP-101
MHRA reference:
GE Healthcare: Centricity PACS IW
FMI 85384
Picture Archiving And Communication System
Model: GE Centricity PACS IW versions
MHRA reference:
Life Technologies: AllSet+ Gold and UniTray
13 April 2015
IVDs, Immunology
Model: AllSet+ Gold and UniTray
MHRA reference:
Medline: security information of Devon鈩� flexible light handle cover
FSCA 15 鈥� 01
Surgical devices, non-powered
Model: Custom specific sets manufactured by Medline Int.
MHRA reference:
Medtronic 3F Therapeutics: 3f Enable鈩� Aortic Bioprosthesis
May 2015
Implants, Non Active, Cardiovascular Heart Valves
Model: 6000
MHRA reference:
Orthofix: Galaxy Unyco Diaphyseal tibia sterile kit
04 May 2015
Surgical Instruments, Implant
Model: 99-93506
MHRA reference:
Philips Medical Systems: DigitalDiagnost
26 March 2015
X Ray, Digital Acquisition Systems
Model: DigitalDiagnost 712027, 712028, 712029
MHRA reference:
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:
Philips Healthcare: DuraDiagnost 3.0/4.0
15 April 2015
Direct Digital Radiography
Model: 712211, 712214
MHRA reference:
Remel Inc: PathoDX Strep Grouping
28 April 2015
IVDs, Bacteriology
Model: PathoDX Strep Grouping (R62031 / R62025)
MHRA reference:
Stephanix: D2RS / DX-D800 / Xcellence Dynamic
D2RS 20150331
Imaging, Patient Support
Model: D2RS / DX-D800 / Xcellence Dynamic
MHRA reference:
Terumo Europe: Terumo庐 Radifocus Guide Wire M
FSN 1502 2015-05
Vascular Cannula/Catheter Accessories
Model: Terumo庐 Radifocus Guide Wire M
MHRA reference:
The Learning Clinic Limited: VitalPAC
April 2015
Diagnostic Measurement and Monitoring
Model: v2.3, v3.0
MHRA reference: