Field Safety Notice: 18 to 22 March 2019
List of field safety notices (FSNs) from medical device manufacturers from 18 to 22 March 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
BioFire Diagnostics: BioFire Diagnostics
15 March 2019
IVDs, bacteriology
MHRA reference: 2019/003/018/487/034
Carestream: Quantum
15 March 2019
X Ray, ancillary equipment and accessories
Model: DRX-Ascend System and Q-Rad System
MHRA reference: 2019/003/019/487/012
ConMed: Anchor Tissue Retrieval System™
March 2019
Surgical instruments, minimal access
MHRA reference: 2019/003/020/701/011
Cordis: Cordis Vista Brite and ADROIT Guiding Catheter
06 March 2019
Vascular cannula and catheters
MHRA reference: 2019/002/008/487/033
Geistlich Pharma: Geistlich Bio-Oss Pen
19 March 2019
Implants, dental
Geistlich Bio-Oss Pen
MHRA reference: 2019/003/020/701/012
Hugh Stepper: Select Myoelectric Hand
RTA N° 9999
Upper limb prosthesis
MYA725RNA - Serial N°1125
MHRA reference: 2019/003/019/601/007
Leica: Leica Biosystems Cryostats
March 2019
IVDs, cytopathology & histopathology
MHRA reference: 2019/003/019/487/008
Marquardt: Staple 1.0mm 90degree
13 March 2019
Osteosynthesis, skeletal pins, wires & staples
MHRA reference:2019/002/005/401/012
Medtronic: Conexus Telemetry - Security Bulletin
21 March 2019
Implants, active, cardiac programmers and remote monitoring
Model: Conexus Telemetry and Monitoring Accessories used with Medtronic ICD, CRT-D, Programmers and
Remote Monitoring - Security Bulletin
MHRA reference: 2019/003/025/487/007
Mikrogen: recomLine Helicobacter 2.0 IgG/IgA
13 March 2019
IVDs, immunology
MHRA reference: 2019/003/019/487/007
Network Medical Products: Coronet
CAPA 216
Surgical instruments, articulated cutting
Model: 51-835-7.50
MHRA reference: 2019/003/015/601/006
Philips: MultiDiagnost Eleva with Flat Detector, Allura Xper systems and Allura Centron
19 February 2019
X Ray, fluoroscopy systems
708037, 708038
722001, 722003, 722005, 722006, 722008,722010, 722011, 722012, 722013, 722014, 722015, 722020, 722023, 722026, 722027, 722028, 722029, 722031, 722035, 722038, 722039, 722058 and 722400.
MHRA reference: 2019/003/005/487/001
Roche: ALBP - Albumin BCP
March 2019
IVDs, clinical chemistry
MHRA reference: 2019/003/006/487/004
Siemens: Syngo Via
04 March 2019
Computed tomography
10496180 - 10561669 and 10561495
MHRA reference: 2019/003/019/601/008
Siemens: ARTISTE; ONCOR; PRIMUS
TH001-19-S
Radiotherapy
08139789; 05863472; 05857912; 07360717; 05857920; 04504200; 01940035; 05500371
MHRA reference: 2019/003/020/601/011
Thermo Fisher: Oxoid CM1106B
20 March 2019
IVDs, bacteriology
MHRA reference: 2019/003/020/601/007
Thermo Fisher Scientific: Oxoid
12 March 2019
IVDs, bacteriology
Model: PO1186A
MHRA reference: 2019/003/013/601/015
Tosoh Corporation: ST AIA-PACK Homocysteine
19 March 2019
IVDs, clinical chemistry
MHRA reference: 2019/003/018/291/011
WEINMANN Emergency Medical Technology
18 February 2019
Lung ventilators
MEDUMAT Transport (WM 28415 und 28315)
MEDUMAT Standard a (WM 22810)
MEDUMAT Standard (WM 22510)
MODUL Oxygen (WM 22175)
MODUL Combi (WM 22177)
ULMER Koffer Verband (WM 8715)
ULMER Koffer Basis (WM8635)
ULMER Koffer Baby (WM 3693)
ULMER Koffer Kreislauf (WM 5225)
MHRA reference: 2019/003/019/291/003