Field safety notices - 11 to 15 May 2015
List of field safety notices (FSNs) from medical device manufacturers from 11 to 15 May 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
View the latest FSNs
Beaver Visitec International: BVI CustomEyes ophthlamic procedure kits
5 May 2015
Lamps and lights
MHRA reference: 2015/005/005/291/030
Beaver Visitec International: BVI viscoelastic solutions
6 May 2015
Implants, non active, intraocular
MHRA reference: 2015/005/006/291/011
Biomet: Optigun Ratchet
9 April 2015
Surgical instruments, implant
MHRA reference: 2015/005/008/051/001
Covidien llc: OxiMax™ N-65 & N-560 pulse oximeter
Oximeter 05/15
Monitors, patient
MHRA reference: 2015/005/013/071/003
Covidien: Puritan Bennett™ 980 series ventilator system
5 May 2015
Lung ventilators
Model: Puritan Bennett™ 980 Series Ventilator System
MHRA reference: 2015/002/017/081/001
Getinge Disinfection: Getinge 86-series
27 April 2015
CSSD wash/clean/drying equipment
Model: S-8666, S-8668
MHRA reference: 2015/005/012/291/005
GYRUS ACMI: Gyrus ACMI Diego Elite Tubeset
29 April 2015
Surgical equipment, miscellaneous
Model: TS101DC, TS100S
MHRA reference: 2015/005/011/601/0082015
Medtronic: Micra transcatheter leadless pacemaker system
8 May 2015
Implants, active, pacemakers
Model: MC1VR01
MHRA reference: 2015/005/011/291/003
Milestone Scientific: Milestone Wand SA hand piece
8 May 2015
Anaesthetic machines and monitors
Model: STA‐5050‐305
MHRA reference: 2015/005/011/291/004
Ortho Clinical Diagnostics: ORTHO VISION™ analyser
May 2015
IVDs, blood transfusion
Model: 6904579
MHRA reference: 2015/005/007/601/001
ReliantHeart: HeartAttendant interface cable
24 April 2015
Implantable ventricular assist devices
Model: M10035
MHRA reference: 2015/004/030/291/002
ResMed: Astral 150
4 May 2015
Lung ventilators
MHRA reference: 2015/005/013/291/003
Roche Diagnostics
FSN-RPD-2014-008
IVDs, clinical chemistry
Model: Drug interference in tests based on the Trinder reaction
MHRA reference: 2015/005/006/701/002
Siemens AG Medical Solutions: Siemens Multix Swing X-ray
DE-BfArM-2015-05-08-1025
X-ray, digital acquisition systems
MHRA reference: 2015/005/008/051/002
Siemens Healthcare Diagnostics: Easylink Informatics System
May 2015
IVDs, clinical chemistry
MHRA reference: 2015/005/007/601/002
Stryker Orthopaedics: Trident PSL HA solid back 50mm
11 May 2015
Joint prosthesis, hip
Model: 540-11-50E
MHRA reference: 2015/005/011/291/008