Field Safety Notice - 04 to 08 September 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 04 to 08 September 2017
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 FSN
Abbott: Alinity hq Analyzer
31 August 2017
IVDs, haematology
Model: Alinity hq Analyzer
MHRA reference: 2017/009/004/291/001
Applied Medical: Kii® Optical Z-Thread Dual Packs
04 September 2017
Surgical instruments, minimal access
Model: CTR14
MHRA reference: 2017/009/005/291/001
Beckman Coulter: AQUIOS CL Flow Cytometer System
31 August 2017
IVDs, haematology
MHRA reference: 2017/009/001/601/014
Biomet
31 August 2017
Osteosynthesis, nails intramedullary
Model: Affixus hip fracture nail
MHRA reference: 2017/009/006/701/010
Braun and Company: SCT Range Braun Tourniquet
31 August 2017
Surgical equipment, tourniquets
Model: SCT Range Braun Tourniquet
MHRA reference: 2017/009/001/601/007
Depuy Synthes: 8cm Angled Attachment
31 August 2017
Surgical power tools
Model: QD8
MHRA reference: 2017/009/004/291/002
Eschmann
07 September 2017
Operating table
Model: T20 & T30
MHRA reference: 2015/011/003/401/002
Ethicon
September 2017
Sutures
Model: VICRYL RAPIDE™ (Polyglactin 910) SUTURE
MHRA reference: 2017/009/005/701/002
Hain Lifesciences GmbH
05 September 2017
IVDs, viral microbiology
GXT NA extraction kit
MHRA reference: 2017/009/006/701/011
Immucor: Capture-R® Ready-ID®; / 0066204 and 0066214
20 February 2017
IVDs, immunology
MHRA reference: 2017/009/006/291/002
Medtronic: DBS Lead Kit for Deep Brain Stimulation
August 2017
Implants, active, leads, neuro
Model: 3387, 3389, 3391
MHRA reference: 2017/003/020/291/021
Mentor: Siltex Round Ultra High Profile Gel Breast Implant
922232
Implants, breast
MHRA reference: 2017/008/031/701/017
Olympus: Working insert; Bridge
1 September 2017
Endoscopes, flexible
Model: A20975A (Working insert, with ramp, one way), A20976A (Bridge, one way), A20977A (Bridge, two way)
MHRA reference: 2017/008/025/701/010
Philips: Mobile Detector Holder
14 July 2017
X Ray, digital acquisition systems
Model: 9890-010-88152
MHRA reference: 2017/009/004/291/004
Radiometer: S7745 AUTOCHECK5+ LEVEL 2
FAN 915-370
IVDs, extra laboratory testing
Model: AUTOCHECK 5+
MHRA reference: 2017/009/004/291/024
SMS Technologies
14 August 2017
Anaesthetic & breathing, medical gas pipelines
Model: 1359808 Medical Nitrous Hose
MHRA reference: 2017/003/010/401/018