Field Safety Notice - 17 - 21 December 2018
List of field safety notices (FSNs) from medical device manufacturers from 17 - 21 December 2018
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
Abbott: ARCHITECT Rubella IgM
18 December 2018
IVDs, viral microbiology
MHRA reference: 2018/012/019/487/013
Bayer: MAVIG® Portegra2 Overhead Counterpoise System
14 December 2018
X ray, ancillary equipment and accessories
MHRA reference: 2018/012/017/701/028
Beckman Coulter: UniCel DxI 600/800 Access Immunoassay Systems, UniCel DxC 660i, 680i, 860i, 880i SYNCHRON Access Clinical Systems
Model number Catalogue number: DxI 800: 973100, A71456, A71457, A84545, A25288, A25285 DxI 600: A30260, A71460, A71461, A92060 DxC 660i: A64871 DxC 680i: A64903 DxC 860i: A64935 DxC 880i: A59102
18 December 2018
IVDs, clinical chemistry
MHRA reference: 2018/012/019/601/008
BIOMERIEUX: VITEK® 2 AST-N351 Test Kit
18 December 2018
IVDs, bacteriology
Model: 421257
MHRA reference: 2018/012/018/291/007
Biomet (Zimmer): Max VPC Instrument Tray & Screw Caddy
20 December 2018
Surgical devices, non-powered
MHRA reference: 2018/012/020/291/007
Cochlear: Baha 5 Sound Processor Tamper-proof battery door 3
20 December 2018
Implants, active, hearing
Model: P1129017
MHRA reference: 2018/012/020/601/003
Convatec (Medtronic): Medtronic MiniMed™ Mio™ Advance Infusion Set 2018121719
Infusion & transfusion, administration sets
MHRA reference: 2018/012/019/487/009
Flexicare: Laryseal Flexi Laryngeal Mask
20 December 2018
Airway devices
MHRA reference: 2018/012/014/487/008
Integra Lifesciences: MAYFIELD® Skull Clamps
14 December 2018
Surgical instruments, articulated holding
Model: A1059, A1108, A1114, A1117, A2000, A2114, A3059
MHRA reference: 2018/012/017/487/012
Medtronic: StealthAir™ Percutaneous Pin Adapter
December 2018
Surgical navigation system and accessories
Model: 9734752
MHRA reference: 2018/012/020/291/002
Nipro: SurdialTM X
20 December 2018
Dialysis, haemodialysis
MHRA reference: 2018/012/012/291/002
Richard Wolf: BRONCHOSKOP-TUBUS;
825200841,825200842,825201041,825201241,825201441 /
06 December 2018
Endoscopes, flexible
MHRA reference: 2018/010/008/228/002
Schiller: CARDIOVIT MS-2007; MS-2010; MS-2015
22 November 2018
ECG
MHRA reference: 2018/012/019/291/005
SCHULTE-ELEKTRONIK: SISS BABYCONTROL
14 December 2018
Monitors, patient
MHRA reference: 2018/012/017/291/008
Siemens: Dimension Vista 1500
December 2018
IVDs, clinical chemistry
MHRA reference: 2018/012/017/601/006
Smith & Nephew: JOURNEY DCF AP Femoral Cutting Block Size 3
13 December 2018
Orthopaedic surgical instruments - Insertion/extraction tools
MHRA reference: 2018/012/020/291/003
Sorin CRM: PLATINIUM ICDs and CRT-Ds
14 December 2018
Implants, active, defibrillators
MHRA reference: 2018/011/029/291/001
Stryker: Tritanium PL Spinal Cage
17 December 2018
Spinal implants
MHRA reference: 2018/012/017/487/013
Terumo: Spectra Optia Apheresis System
December 2018
Apheresis
Model: 61000
MHRA reference: 2018/012/010/291/005