Field Safety Notices - 10 - 14 October 2016
Summary List of field safety notices (FSNs) from medical device manufacturers from 10 - 14 October 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: Lactic Acid
10 October 2016
IVDs, clinical chemistry
MHRA reference: 2016/010/012/701/010
Boston Scientific: Vascular Guide Catheter, single-use
RA2016-124
Vascular cannula and catheters Model: Vascular Guide Catheter
MHRA reference: 2016/010/007/701/008
Corin: LARS
12 October 2016
Ligaments, tendons and anchors
Model: 104.002
MHRA reference: 2016/010/012/601/010
Covidien: Clearify Visualization System
October 2016
Endoscopes, flexible
Model: Clearify Visualization System
MHRA reference: 2016/010/007/701/010
Drive Medical: Able Assist
30 September 2016
Moving & handling
MHRA reference: 2016/006/021/291/016
Edwards: Edwards Commander Delivery System
August 2016
Vascular cannula and catheters
Model: 9610TF23, 9610TF26, 9610TF29
MHRA reference: 2016/005/020/701/021
GE: Brivo OEC 715/785/865
4 October 2016
X Ray, fluoroscopy systems
MHRA reference: 2016/010/010/291/007
Gabmed: gabControl D-Dimer Test
12 October 2016
Coagulation
MHRA reference: 2015/010/022/294/001
Greatbatch Medical:Surgical Instrument Torque Limiter
July 2016
Orthopaedic surgical instruments - Insertion/extraction tools
Model: 00-2360-080-00, 00-2360-080-05, T13621, T112972, T116430, T14378, T14379, T14380, T14000, T14001, T116245
MHRA reference: 2016/010/003/291/012
One Lambda: LABType DNA Typing Tests
29 September 2016
IVDs, immunology
MHRA reference: 2016/010/007/701/009
St. Jude Medical: Implantable Cardioverter Defibrillator
10 October 2016
Implants, active, defibrillators
Model: various as per FSN
MHRA reference: 2016/009/012/291/008
TRUMPF: Universal Arm Support
31 March 2016
Operating table Model: various as per FSN MHRA reference: 2016/010/011/701/010