Field Safety Notice: 1 to 5 July 2019
List of field safety notices (FSNs) from medical device manufacturers from 1 to 5 July 2019
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
A&E Medical: MYO/WIRE® ULTRA-FLEX
21 June 2019
Pacemakers, external
M-21 Series (021-001, 021-010, 021-011)
MHRA reference: 2019/007/001/487/002
Biomet (Zimmer): Ultra-Drive® Hose/Drape Assembly and Ultra-Drive® Irrigation Tubing Assembly
27 June 2019
Surgical power tools MHRA reference: 2019/006/028/228/007
Bracco: Day Set III HP
19 June 2019
Media injectors
640060
MHRA reference: 2019/006/028/228/001
Edwards Life Sciences: Edwards CENTERA™ Transcatheter Heart Valve System
FCA 140 Implants, non-active, cardiovascular heart valves 9551S23, 9551S26, 9551S29 MHRA reference: 2019/007/003/291/002
Elekta: Monaco RTP System
June 2019
Radiotherapy planning and verification systems
MHRA reference: 2019/007/004701/024
Grace Medical: Cartilage Microtome System
21 June 2019
IVDs, cytopathology & histopathology
MHRA reference: 2019/007/001/487/001
Grouleff-DK: Stitching Unit
09 May 2019
Trolleys and chairs
Model: G160510 0800-01-019
MHRA reference: 2019/005/013/701/004
Heidelberg Engineering: SPECTRALIS
02 July 2019
Computed tomography
All models.
MHRA reference: 2019/007/002/601/003
Intuitive Surgical: da Vinci® Xi™ EndoWrist® SureForm 60 Reload
ISIFA2019-05-R
Staples and staple guns
48360T-08; 48360G-08
MHRA reference: 2019/006/027/701/008
Medtronic: Medtronic MiniMed Paradigm® Infusion Pumps; Medtronic MiniMed Paradigm® VEOTM; Medtronic MiniMed Infusion Pump
June 2019
Infusion systems
Model: MMT-512, MMT-712, MMT-515, MMT-715, MMT-522,
MMT-722; MMT-554, MMT-754, MMT-508
MHRA reference: 2019/006/028/487/010
Phadia (ThermoFisher): Phadia 1000
QA2019-03
IVDs, clinical chemistry
12-3800-01
MHRA reference: 2019/007/001/601/003
Roche: Elecsys Anti-CCP. See under "Accessories"
July 2019
IVDs, Immunology
Elecsys Anti-CCP
MHRA reference: 2019/007/004/701/011
RSR: RiaRSR AChRAb
06 June 2019
IVDs, immunology
MHRA reference: 2019/006/027/601/002