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’s field safety notices in our filecamp folder.

B.Braun Medical: Aesculap Sillar Templet

20 January 2015

Device description: surgical instruments, implant

Model: GB-315-20-E

MHRA reference: 2015/001/016/601/008

 

Baxter Healthcare: Various brands (see FSN)

February 2015

Device description: dialysis, peritoneal

Model: various models (see FSN)

MHRA reference: 2015/002/013/081/038

 

Biomet UK: Rebalance Ankle Talar Culcus Guides

11 December 2014

Device description: surgical instruments, implant

MHRA reference: 2015/002/013/701/002

 

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: 2015/002/011/081/018

 

EOS Imaging: EOS

17 February 2015

Device description: X-ray, digital acquisition systems

MHRA reference: 2015/002/019/071/006

 

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: 2015/002/019/181/003

 

 

IBA Dosimetry: COMPASS

28 January 2015

Device description: radiotherapy

MHRA reference: 2015/002/013/081/003

 

 

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: 2015/002/019/181/002

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: 2015/002/019/181/001

Siemens Healthcare Diagnostic Products: IMMULITE

February 2015

Device description: IVDs, clinical chemistry

Model: L2KGI2 SMN#10380988

MHRA reference: 2015/002/013/601/009

 

Siemens Healthcare Diagnostics: ADVIA Chemistry XPT System

February 2015 11219636 Rev A

Device description: IVDs, clinical chemistry

Model: SMN 10723034

MHRA reference: 2015/002/017/601/007

 

Siemens Healthcare Diagnostics: ADVIA Centaur XPT

11219636 Rev A

Device description: IVDs, clinical chemistry

MHRA reference: 2015/002/017/601/004

 

St Jude Medical: Nanostim™ Leadless Pacemaker

20 February 2015

Device description: implants, active, pacemakers

Model: Nanostim™ Leadless Pacemaker - S1DLCP

MHRA reference: 2015/002/020/131/004

 

Terumo Cardiovascular Systems: Titan™ and Titan™ 360 Stabilizer Attachments

FSN1406 2015-02

Device description: endoscopes, flexible

Model: 401-231 and 401-231U

MHRA reference: 2015/002/012/701/007

 

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

 

16 February 2015

Device description: lung ventilators

MHRA reference: 2015/002/017/081/00116

 

Zefon International: InfuseIT® Disposable Pressure InfusorFFF341

13 February 2015

Device description: infusion and transfusion, administration sets

Model: InfuseIT® Disposable Pressure Infusor

MHRA reference: 2014/007/009/401/010

 

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