Field safety notices - 16 to 20 February 2015
Read the official alert on GOV.UK — MedRegWatch re-presents it; GOV.UK is the authoritative source.
| Type | Field safety notice (devices) |
|---|---|
| Issued | 20 Feb 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