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