Field Safety Notice - 14 to 18 May 2018
Summary List of field safety notices (FSNs) from medical device manufacturers from 14 to 18 May 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
ArjoHuntleigh: Akron Tilt Table
FSN-POZ-002-2018
Trolleys and chairs
Model: A8652, A8652T
MHRA reference: 2018/005/011/601/003
Datascope (Getinge)
04 May 2018
Cardiac assist pumps
Model: Circulatory assist system, intra-aortic balloon
MHRA reference: 2018/005/010/228/001
Gambro (Baxter): Prismaflex System
May 2018
Dialysis, haemofilters
Model: 107493
MHRA reference: 2018/005/016/291/010
Immucor: Panocell-10 Ficin Set 23x3,1x2
23 January 2018
IVDs, blood transfusion
Model: 0002385
MHRA reference: 2018/005/017/291/004
Implant Direct: Legacy™ Implant Closed‐Tray Transfer-Concave
May 2018
Implants, dental
Model: 8735-05
MHRA reference: 2018/005/017/601/001
Intuitive Surgical: EndoWrist Stapler Release Kit
ISIFA2017-02-C Phase II
Endoscopes, rigid
Model: 381215-03; 381381-02; 381382-02; 381383-02; 381384-02; 381385-02; 381386-02; 381387-02; 381388-02; 381389-02; 381393-02; 381395-02; 381401-02; 381402-02; 381403-02
MHRA reference: 2018/005/018/478/018
Ortho Clinical Diagnostics: VITROS Chemistry Products PHYT Slides
10 May 2018
IVDs, clinical chemistry
Model: 8298671
MHRA reference: 2018/005/013/601/001
Philips: FlexCardio
December 2017
Monitors, patient
Model: 722458 & 722459 Flex Cardio
MHRA reference: 2018/005/015/478/001
Philips: OmniDiagnost Classic & Eleva
01 May 2018
X Ray, fluoroscopy systems
MHRA reference: 2018/005/011/478/010
Siemens Healthcare: N Latex CDT Kit
May 2018
IVDs, clinical chemistry
MHRA reference: 2018/005/017/701/002
Teleflex (Arrow International): Various
09 May 2018
Vascular cannula and catheters
MHRA reference: 2018/005/011/478/009