Field safety notices - 14 November - 18 November 2016
Summary List of field safety notices (FSNs) from medical device manufacturers from 14 November - 18 November 2016
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
Abbott: ARCHITECT Toxo IgM
14 November 2014
IVDs, viral microbiology
MHRA reference: 2016/011/015/701/016
Bayer: Medrad® IntegoPET Source Administration Sets
November 2016
Infusion & transfusion, administration sets
MHRA reference: 2016/011/010/291/009
B. Braun: Dialog+ Dialysis machines with SW 8.2A with option Adimea fitted
14 October 2016
Dialysis, haemodialysis
Model: Dialog+ - complete list to follow
MHRA reference: 2016/010/014/601/010
Depuy Synthes
11 November 2016
Surgical instruments, non-articulated cutting
Model: 352.044; 352.040
MHRA reference: 2016/011/016/299/014
Handicare: Vertical Support
1 November 2016
Hoists and slings
Model: 50400242, 50400190, 50400235
MHRA reference: 2016/011/007/291/004
IMPAC Medical: Monaco RTP System
October 2016
Radiotherapy planning and verification systems
MHRA reference: 2016/011/014/701/006
Medline International: Sterile Procedure Trays
26 October 2016
Surgical devices, non-powered
MHRA reference: 2016/011/004/701/018
Medtronic: Affinity Fusion™ Oxygenator with Integrated Arterial Filter and CVR
November 2016
Infusion and transfusion, heart lung circuits
Model: BB841
MHRA reference: 2016/011/016/299/023
Research Instruments: EZ-Tip
3 October 2016
Laboratory equipment associated with IVF, cells, tissues
MHRA reference: 2016/010/003/701/006
Siemens: AXIOM Artis systems with SW version VB35E
27 October 2016
X-ray, fluoroscopy systems
MHRA reference: 2016/011/016/601/007
Siemens: SOMATOM Definition AS and SOMATOM Definition Flash
4 October 2016
Computed tomography
Model: 08098027 (SOMATOM Definition AS), 10430603 (Flash)
MHRA reference: 2016/011/016/601/010
Siemens: Business Area Advanced Therapies: Artis Q systems with SW version VD11
27 October 2016
X Ray, Fluoroscopy dystems
Model: all Artis Q systems with SW version VD11 and Gigalix X-ray tubes
MHRA reference: 2016/011/016/601/005
Siemens: Business Area Advanced Therapies: Artis zee systems with SW version VC21C, VD11
27 October 2016
X Ray, Fluoroscopy systems
Model: Artis zee systems with SW version VC21C, VD11 and MegalixCat + X-ray tubes
MHRA reference: 2016/011/016/601/008
Ulrich: Surgical Technique uCentum - Locking Screw
I-00227
Osteosynthesis, bone screws
Model: CS 3801-01 – Locking Screw
MHRA reference: 2016/011/016/299/011
Ulthera: Cellfina System
14 November 2016
Surgical devices, non-powered
MHRA reference: 2016/011/015/701/007
Various: heater/cooler units
11 November 2016
Blood/fluid warming systems
MHRA reference: 2014/007/016/081/003
Wright Various
8 November 2016
Sterilization, healthcare
MHRA reference: 2016/011/011/291/016