Field safety notices - 9 to 13 November 2015

List of field safety notices (FSNs) from medical device manufacturers from 9 to 13 November 2015.

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

Aesculap AG: Flexible screw driver

11 September 2015

Surgical instruments, implant

Model: SJ706R

MHRA reference: 2015/011/010/701/007

ArthroCare Corporation: Cavity SPINEWAND device, 8-gauge

5 November 2015

Therapy tissue ablation

MHRA reference: 2015/011/005/291/006

Baxter Healthcare: Vented Paclitaxel set

November 2015

Infusion and transfusion, administration sets

Model: VMC9627 (14A08V008, 14F14V705, 14G16V016, 14I05T696, 14K19T380, 14L12T673, 15A12T126, 15B17T404); MMC9627S (14H13V434); AMC9627 (14H04V366, 14I01T752).

MHRA reference: 2015/011/011/299/004

Becton Dickinson Diagnostics: BD CD22 (S-HCL-1) APC (CE-IVD)

5 November 2015

IVDs, cytopathology & histopathology

Model: BD CD22 (S-HCL-1) APC (CE-IVD) (333145)

MHRA reference: 2015/011/010/601/015

B. Braun Melsungen AG: spiral line, ProSet

20 October 2015

Infusion & transfusion, administration sets

Model: 4092937 and 4092945

MHRA reference: 2015/010/020/601/010

Depuy Synthes GmbH: DHS connecting screws

9 April 2015

Osteosynthesis, bone screws

Model: 03.224.007

MHRA reference: 2015/004/020/291/009

Depuy Synthes: Locking screw Stardrive, setf-tapping.412.104S, 412.105S, 413.016,

12 November 2015

Osteosynthesis, bone screws

MHRA reference: 2015/011/009/299/006

Fenland Laundries: Micronclean sterile packs

11 November 2015

Injection devices

MHRA reference: 2015/009/029/292/010

GE Medical Systems: Revolution CT

FMI 25465

Computed tomography

Model: 5480177

MHRA reference: 2015/011/006/292/005

Implant Direct Sybron Manufacturing: DGDE - DirectGuide Drill Extender

3 November 2015

Dental, laboratory equipment

MHRA reference: 2015/011/005/601/015

Leonhard Lang: 59356 ECG electrode SKINTACT W-60

3 November 2015

ECG

MHRA reference: 2015/011/005/291/008

Medtronic Inc: InSync III cardiac resynchronization therapy pacing (CRT-P)

November 2015

Implants, active, pacemakers

Model: 8042

MHRA reference: 2015/011/010/131/003

Molnlycke Health Care:BARRIER EasyWarm

4 November 2015

Heating, Patient, Electrical Pads & Blankets

Model: 629900, 629910

MHRA reference: 2015/011/010/131/004

Pari GmbH: PARI SOLE N / PARI SOLE Tracheo

26 October 2015

Nebulizers

MHRA reference: 2015/011/009/299/005

Philips: Flex Cardio patient monitoring system

19 October 2015

Monitors, patient

Model: 453564243591 XPer Flex Cardio 2010, 453564241901 XPer Flex Cardio 2010-Exchange

MHRA reference: 2015/011/010/131/001

Philips Medical: Allura Xper FD R8.2.1.1

20 October 2015 (FCO72200327) X-ray, fluoroscopy systems

Model: 722026, 722027, 722028, 722029, 722038, 722058, 722033, 722034, 722035, 722036, 722039, 722059

MHRA reference: 2015/011/009/292/011

Philips Medical: Allura Xper FD R8.2.0

20 October 2015 (FCO72200284) X-ray, fluoroscopy systems

Model: 722026, 722027, 722028, 722029, 722038, 722058, 722033, 722034, 722035, 722036, 722039, 722059

MHRA reference: 2015/011/009/292/012

Ortho Clinical Diagnostics: VITROS 3600 system & VITROS 5600 system

November 2015

IVDs, clinical chemistry

MHRA reference: 2015/011/006/601/013

Ortho Solutions: FPS 2.7MM locking screw 8MM,12MM,14MM, 16MM, 26MM,30MM

5 November 2015

Osteosynthesis, bone screws

MHRA reference: 2015/011/009/291/001

Roche Diabetes Care GmbH: Accu-Chek Insight Rapid

SB_RDC_2015_07

Infusion & transfusion, administration sets

Model: 00700008451, 00700008452, 00700008453, 00700008454, 00700008455, 00700008456, 00700008457, 00700008458, 00700008459

MHRA reference: 2015/010/026/701/014

Siemens Healthcare Diagnostics: Dimension integrated chemistry systems RMS modules

November 2015

IVDs, clinical chemistry

MHRA reference: 2015/011/011/601/004

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