Field safety notices - 16 to 20 February 2015

List of field safety notices (FSNs) from medical device manufacturers from 16 to 20 February 2015.

You can see copies of this week鈥檚 field safety notices in our .

B.Braun Medical: Aesculap Sillar Templet

20 January 2015

Device description: surgical instruments, implant

Model: GB-315-20-E

MHRA reference:

Baxter Healthcare: Various brands (see FSN)

February 2015

Device description: dialysis, peritoneal

Model: various models (see FSN)

MHRA reference:

Biomet UK: Rebalance Ankle Talar Culcus Guides

11 December 2014

Device description: surgical instruments, implant

MHRA reference:

CellPath: EAM-XXXX SYSTEM II+ (SLOTTED) var LOOSE, HOPPERED

03 February 2015

Device description: IVDs, specimen receptacles

Model: EAM-0102-04H; EAM-0108-04H; EAM-0109-04H, EAM-0107-03A; EAM-0111-03A

MHRA reference:

EOS Imaging: EOS

17 February 2015

Device description: X-ray, digital acquisition systems

MHRA reference:

GE Hualun Medical Systems Co: Proteus XR/a

FMI 17108

Device description: X-ray, ancillary equipment and accessories

Model: Proteus XR/a with wall stand model number 2260354

MHRA reference:

IBA Dosimetry: COMPASS

28 January 2015

Device description: radiotherapy

MHRA reference:

Philips Medical Systems: Allura Xper Systems

08 January 2015, manufacturer ref FCO72200269

Device description: X-ray, ancillary equipment and accessories

Model: Allura systems. Actuator Monitor Ceiling Suspension (MCS)

MHRA reference:

Philips Medical Systems: Allura Xper Systems

08 January 2015, manufacturer ref FCO72200274

Device description: X-ray, ancillary equipment and accessories

Model: Allura systems. Actuator Monitor Ceiling Suspension (MCS)

MHRA reference:

Siemens Healthcare Diagnostic Products: IMMULITE

February 2015

Device description: IVDs, clinical chemistry

Model: L2KGI2 SMN#10380988

MHRA reference:

Siemens Healthcare Diagnostics: ADVIA Chemistry XPT System

February 2015 11219636 Rev A

Device description: IVDs, clinical chemistry

Model: SMN 10723034

MHRA reference:

Siemens Healthcare Diagnostics: ADVIA Centaur XPT

11219636 Rev A

Device description: IVDs, clinical chemistry

MHRA reference:

St Jude Medical: Nanostim鈩� Leadless Pacemaker

20 February 2015

Device description: implants, active, pacemakers

Model: Nanostim鈩� Leadless Pacemaker - S1DLCP

MHRA reference:

Terumo Cardiovascular Systems: Titan鈩� and Titan鈩� 360 Stabilizer Attachments

FSN1406 2015-02

Device description: endoscopes, flexible

Model: 401-231 and 401-231U

MHRA reference:

Tyco Healthcare UK Ltd / Covidien: Puritan Bennett鈩� 980 Series Ventilator System

16 February 2015

Device description: lung ventilators

MHRA reference:

Zefon International: InfuseIT庐 Disposable Pressure InfusorFFF341

13 February 2015

Device description: infusion and transfusion, administration sets

Model: InfuseIT庐 Disposable Pressure Infusor

MHRA reference:

Updates to this page

Published 20 February 2015