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
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