Field Safety Notice - 24 September to 28 September
List of field safety notices (FSNs) from medical device manufacturers from 24 September to 28 September
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
B Braun: 220-240V Unit Cable (power cord)
17 September 2018
Infusion systems
Model: 34502718
MHRA reference: 2018/009/020/601/003
Bayer: Low Volume IV Filter / BC 693
19 September 2018
Infusion & transfusion, administration sets
MHRA reference: 2018/009/019/291/004
Beckman Coulter: Kaluza C Software
21 September 2018
IVDs, cytopathology & histopathology
MHRA reference: 2018/009/025/601/006
CooperSurgical: Single-Use, Colpo-Pneumo Occluder
04 September 2018
Surgical instruments, minimal access
Model: Single-Use, Colpo-Pneumo Occluder - CPO-6
MHRA reference: 2018/009/024/081/019
Endologix: Ovation Abdominal Stent Graft System Platform
26 September 2018
Implants, non active, endoprostheses for aortic aneurysms
Model: TV-AB2080-D, TV-AB2380-D, TV-AB2680-D, TV-AB2980-D, TV-AB3480-D, TV-AB2080-I, TV-AB2380-I, TV-AB2680-I, TV-AB2980-I, TV-AB3480-I
MHRA reference: 2018/009/027/701/037
GE Healthcare: Millennium MG, Millennium MC, Millennium MYOSIG
FMI 40878
Nuclear medicine, gamma camera systems & accessories
MHRA reference: 2018/009/026/228/004
Gambro (Baxter): AK 98
25 September 2018
Dialysis, haemodialysis
Model: 15244, 115248, 115249, 115250, 955106, 955403, 955404
MHRA reference: 2018/009/014/000/009
Heraeus: COPAL® knee moulds
13 July 2018
Bone cement and tools
MHRA reference: 2018/007/017/291/003
Orthofix: DRILL BITS
24 September 2018
Surgical power tools
MHRA reference: 2018/009/026/701/019
RaySearch Laboratories: RayStation
21 September 2018
Radiotherapy planning and verification systems
Model: RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7
MHRA reference: 2018/009/025/701/011
Robinson Healthcare: Instrapac
14 September 2018
Surgical instruments, articulated holding
MHRA reference: 2018/009/019/601/006
Siemens: ARTIS pheno
06 September 2018
X ray, fluoroscopy systems
MHRA reference: 2018/009/024/601/001
Smiths Medical: Portex® Bivona® Inner Cannula Tracheostomy Tube
11 September 2018
Airway devices
Model: BRC270, BRC275, BRC280, BRC285, BRC290
MHRA reference: 2018/009/021/291/006
Stryker: Stryker Model 8001 Altrix
September 2018
Heating, patient, electrical pads & blankets
MHRA reference: 2018/009/017/000/007
Teleflex: CrystalClear Plus RUSCH CARE CrystalClear (PVC) Tracheostomy Cannula (no Cuff) - Set RUSCH CrystalClear (PVC) Tracheostomy Cannula (Cuffed) RUSCH CrystalClear (PVC) Tracheostomy Cannula (no Cuff)
21 September 2018
Airway devices
MHRA reference: 2018/009/024/081/005