Field Safety Notice - 19 to 23 March 2018
Summary List of field safety notices (FSNs) from medical device manufacturers from 19 to 23 March 2018
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
Acutronic: fabian Therapy evolution
19 March 2018
Lung ventilators
Model: 121001
MHRA reference: 2018/003/021/291/001
Bentley InnoMed: BeGraft Peripheral Stent Graft System
19 March 2018
Implants, non active, peripheral vascular stents
MHRA reference: 2018/003/021/291/004
Caesarea Medical Electronics:100-100SM T34 Ambulatory Syringe Pump
07 March 2018
Infusion systems
MHRA reference: 2018/002/026/291/004
Cook Medical: StoneBreaker Pneumatic Lithotripter
07 March 2018
Lithotripsy, external and internal
MHRA reference: 2018/003/021/478/020
Covidien (CardinalHealth): Yankauer Suction Tubing Penrose Tubing Trocar Catheter Thoracic Catheter
19 March 2018
Suction equipment
MHRA reference: 2018/003/021/291/002
GE Vingmed Ultrasound AS:TEE Probes
76177-2
Ultrasound, imaging
MHRA reference: 2018/003/019/291/006
Implant Direct Sybron Manufacturing LLC: simply InterActive® Implant
March 2018
Implants, Dental
Model: 655010U
MHRA reference: 2018/003/015/601/016
Intuitive Surgical: da Vinci X Surgical System
ISIFA2018-02-C
Endoscopes, rigid
MHRA reference: 2018/003/016/701/013
Kimal: Altius Central Venous Catheter Kit
March 2018
Vascular cannula and catheters
MHRA reference: 2018/003/021/291/020
Macopharma: Easyflex PVC
19 March 2018
Infusion & transfusion, administration sets
MHRA reference: 2018/003/021/291/003
Micronclean LTD: MicronDevices Sterile Packs
21 March 2018
Injection devices
MHRA reference: 2018/003/022/291/002
Polymer Technology Systems Diagnostics: PTS Panels CHOL+GLU Test Panel Test Strips
13 March 2018
Instrumentation/ platform
MHRA reference: 2018/003/021/478/013
Siemens Healthcare: Primus, Oncor
TH009/17/S
Radiotherapy
Model: 01940035, 04504200, 05857912, 05857920, 05863472,
MHRA reference: 2018/003/009/601/008
Siemens: Syva Emit II Plus 6-Acetylmorphine assay
March 2018
IVDs, clinical chemistry
Model: SMN 10481483 and SMN 10470440
MHRA reference: 2018/003/016/601/001
Smith & Nephew: PERI-LOC VOL DIST RAD LCK PL STD HD 9H SH R 135MM
14 March 2018
Osteosynthesis, bone plates
MHRA reference: 2018/003/020/478/010
Stryker: EMS – Power-LOAD® Cot Fastener
March 2018
Moving & handling
MHRA reference: 2018/003/020/478/011
Thermofisher Scientific: Remel
23 February 2018
IVDs, bacteriology
Model: Remel R30166601
MHRA reference: 2018/003/020/601/002
Venner Medical Singapore: Venner™ Tracheal Seal Monitor
23 February 2018
Airway devices
Model: 90320
MHRA reference: 2018/003/021/291/019
William A Cook Australia (Cook Medical): Vacuum Pump
08 March 2018
Surgical equipment, miscellaneous
Model: K-MAR-5200
MHRA reference: 2018/003/016/701/039
Zimmer: Normed Charcot Osteotome Chisel
16 March 2018
Osteosynthesis, bone plates
Model: 26.08.506; 26.08.507; 26.08.508; 26.08.509; 26.08.613; 26.08.619;
MHRA reference: 2018/003/016/228/001