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