Field Safety Notices: 27 June to 1 July 2022
Summary List of field safety notices (FSNs) from medical device manufacturers from 27 June to 1 July 2022
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 a list of FSNs published since January 2020
View FSNs since November 2014. FSNs before this date are on the National Archives website
Abbott: Hemoglobin A1c
09 June 2022
IVDs, Haematology
MHRA reference: 2022/006/013/701/032
GE: Centricity Universal Viewer Zero Footprint client
85465
Picture Archiving And Communication System (PACS)
MHRA reference: 2022/006/029/599/001
Hamilton Medical: 160021 HAMILTON-C6
24 June 2022
Ventilator
MHRA reference: 2022/006/015/611/001
Integra: Codman® CereLink® ICP Monitor
22 June 2022
Monitors, Patient
Model: 826820
MHRA reference:2022/006/028/613/008
Kimal: Procedure Packs
23 May 2022
Basic Dressings, Absorbents, Swabs, Procedure Packs
Model:K20253,K2386/P1,K26254,K34027/P1,K38026,K46064/P1,K48787,K53899/P1,K54146/P1/PSP,K56673,K66150/P1,QA-K3372
MHRA reference: 2022/005/023/601/001
Medtronic: Cobalt XT, Cobalt, Crome Implantable Cardioverter/Defibrillator Systems
June 2022
Implants, Active, Defibrillators
Model: Cobalt XT VR: DVPA2D1, DVPA2D4 Cobalt XT DR: DDPA2D1, DDPA2D4 Cobalt XT HF: DTPA2D4, DTPA2D1 Cobalt XT HF Quad: DTPA2QQ, DTPA2Q1 Cobalt VR: DVPB3D1, DVPB3D4 Cobalt DR: DDPB3D1, DDPB3D4 Cobalt HF: DTPB2D4, DTPB2D1 Cobalt HF Quad: DTPB2QQ, DTPB2Q1 Crome VR: DVPC3D1, DVPC3D4 Crome DR: DDPC3D1, DDPC3D4 Crome HF: DTPC2D4, DTPC2D1 Crome HF Quad: DTPC2QQ, DTPC2Q1 Cobalt XT HF Quad: DTPA2D1G, DTPA2QQ
MHRA reference: 2022/006/024/595/005
Nuvasive: Simplify Artificial Cervical Disc
13 June 2022
Spinal Implants
MHRA reference: 2022/006/020/601/010
Siemens: Artis Zeego
May 2022
X Ray, Fluoroscopy Systems
MHRA reference: 2022/005/024/601/503
Stryker: 1688 Camera Control Unit (CCU)
May 2022
Endoscopes, Televisual Systems
MHRA reference: 2022/002/022/291/001