Field safety notices - 6 to 13 July 2015
List of field safety notices (FSNs) from medical device manufacturers from 6 to 13 July 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
Baxter Healthcare: sterile water for irrigation, 1000 ml (code UKF7114) 0.9% sodium chloride for irrigation, 1000 ml (code UKF7124)
July 2015
Surgical equipment, miscellaneous
MHRA reference: 2015/007/006/291/013
Brainlab AG: iPlan RT Dose
12 June 2015
Radiotherapy planning and verification systems
MHRA reference: 2015/007/003/701/007
CareFusion: Vital Signs Light Wand stylet and Light Wand pack
June 2015
Airway devices
MHRA reference: 2015/007/008/291/001
Depuy Synthes: Technique guide reamer/irrigator/aspirator (RIA)
01 July 2015
Surgical instruments, implant
Model: 036.000.553
MHRA reference: 2015/007/007/291/009
Dräger Medical: Sola 500/700; G93358, G93359
May 2015
Lamps & lights
MHRA reference: 2015/007/009/291/007
Dräger Medical: Evita Infinity V500, Babylog VN500, Evita V300
June 2015
Lung ventilators
MHRA reference: 2015/007/007/291/002
Medtronic: Engager Bioprosthesis
July 2015
Implants, non-active, cardiovascular heart valves
Model: Percutaneous Valve / Transcatheter Valve –Thv ME-TA2-823
MHRA reference: 2015/006/024/291/007
Philips Medical: ACS-NT, Intera 1.5T, Achieva 1.5T
June 2015
Magnetic resonance, equipment & accessories
Model: 78107, 781105, 781105, 781106, 781107, 781108, 781153, 781160, 781170, 781171, 781172, 781173, 781174, 781175, 781176, 781178, 781195, 781196, 781253, 781283, 781295, 781296, 781343, 781346, 781382
MHRA reference: 2015/007/007/291/014
Pulsion Medical Systems: PiCCO catheter
30 June 2015
Vascular cannula and catheters
Model: PV2014L08-A and PV2014L50-A
MHRA reference: 2015/007/009/701/015
Roche Diagnostics: Reflotron uric acid test
01 July 2015
IVDs, extra laboratory testing
Model: Reflotron uric acid, Reflotron PST uric acid, and Reflotron uric acid II
MHRA reference: 2015/007/006/701/008
Siemens Healthcare: ARTIS ZEE floor; ARTIS ZEE ceiling
15 June 2015
X-ray, fluoroscopy systems
MHRA reference: 2015/007/007/601/509
Siemens Medical Solutions: E. CAM
MI008/15/S including MI009/15/S
Nuclear medicine, gamma camera systems & accessories
Model: 4380213, 4380221, 10520745, 5242826, 5977066, 5977074
MHRA reference: 2015/007/007/601/503
Siemens Medical Solutions: ACUSON S family (S1000, S2000, S3000)
UI US013/15/S
Ultrasound, imaging
Model: 10441701, 10041461, 10441730, 10440017
MHRA reference: 2015/007/007/601/504
Siemens Medical Solutions: ACUSON S2000, S3000 with virtual touch IQ option
UI US014/15/S
Ultrasound, imaging
Model: 10041461, 10440017 and 10441730
MHRA reference: 2015/007/007/601/505
Siemens Medical Solutions: ACUSON S family
UI US016/15/S
Ultrasound, imaging
Model: 10041461, 10441701, 10441730
MHRA reference: 2015/007/007/601/506
Stryker Trauma: rHead, uHead, Sigmoid Notch, ReMotion, Radio Capitellum
03 July 2015
Joint prosthesis, elbow
Model: see FSN
MHRA reference: 2015/007/007/291/001
Thermofisher Scientific: Oxoid MacConkey Agar No. 3 (DCM)
7 July 2015
IVDs, bacteriology
Model: CM0115B
MHRA reference: 2015/007/009/601/003
TRUMPF Medizin Systeme: klinoPORT
24 June 2015
Examination/treatment lamp
Model: 4027210; 4027410; 4027510
MHRA reference: 2015/007/003/701/002
Vygon SA - c/o Vygon: Y connector 8-10mm
3 July 2015
Infusion & transfusion, administration sets
Model: 0884.08
MHRA reference: 2015/007/003/601/501
Zethon: Monopolar and bipolar cables
08 July 2015
Surgical, diathermy
MHRA reference: 2015/006/030/291/003
Zimmer Biomet UK: RHK knee femoral component
30 June 2015
Joint prosthesis, knee
MHRA reference: 2015/007/006/291/001