Field Safety Notices - 25 July - 29 July 2016
Summary List of field safety notices (FSNs) from medical device manufacturers from 25 - 29 July 2016
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
Agfa Healthcare: DX-D 600
PRB0052065 - VR0000310
X Ray, digital acquisition systems
MHRA reference: 2016/004/027/701/017
Alere Technologies AS: Alere Afinion™ CRP
July 2016
IVDs, clinical chemistry
MHRA reference:2016/007/025/701/002
Bausch + Lomb: 1,5 mmx1,7mm TRAPEZOID ANGLED 6/BOX MAXZ170
27 June 2016
Surgical instruments, non-articulated cutting Model: 1,5 mmx1,7mm TRAPEZOID ANGLED 6/BOX MAXZ170 E7599
MHRA reference: 2016/006/030/291/003
Biomet: BIOMET 360 TIBIAL AUG
6 April 2016
Joint prosthesis, knee
MHRA reference: 2016/004/008/701/008
CSC: iLAB
20 June 2016
IVDs, clinical chemistry
MHRA reference: 2016/007/025/299/002
Cellnovo: Cellnovo
15 July 2016
Infusion systems Model: 2000041
MHRA reference: 2016/007/015/601/007
Covidien: Covidien Valleylab™ Laparoscopic Electrodes
15 July 2016
Surgical, diathermy MHRA reference: 2016/007/014/701/008
Hangzhou Biotest Biotech: RightSign HIV 1.2.O Rapid Test Cassette RightSign HCV Rapid Test Cassette RightSign HBsAg Rapid Test Cassette
20 June 2016
IVDs, viral microbiology
MHRA reference: 2016/006/020/291/004
Intuitive Surgical: da Vinci Xi EndoWrist Stapler (Stapler 45, Stapler 30, Stapler 30 Curved-Tip)
22 July 2016
Endoscopes, rigid
Model: 470298, 470430, 470530
MHRA reference: 2016/007/025/299/006
Maquet: CARDIOSAVE Hybrid IABP, CARDIOSAVE Rescue IABP
14 June 2016
Cardiac assist pumps MHRA reference: 2016/007/021/291/001
McKesson: McKesson Radiology (MR)
12 July 2016
Picture archiving and communication system Model: McKesson Radiology (MR) 12.1.1
MHRA reference: 2016/007/021/291/005
Medtronic: O-arm® 1000 Surgical Imaging System, O-arm® O2 Surgical Imaging System
July 2016
X Ray, fluoroscopy systems MHRA reference: 2016/007/020/299/002
Merge: Merge CADstream
13 July 2016 (2016-022)
Picture Archiving and Communication System (PACS) MHRA reference: 2016/006/028/601/024
Merge: Merge CADstream
13 July 2016 (2016-023/024)
Picture Archiving and Communication System (PACS) MHRA reference: 2016/006/028/601/015
Merge: Eye Station
13 July 2016
Picture Archiving and Communication System (PACS)
MHRA reference: 2016/006/028/601/009
Merge: Eye Station
13 July 2016 (2016-044)
Picture Archiving and Communication System (PACS) MHRA reference: 2016/006/029/601/010
Merge: Eye Station
13 July 2016 (2016-039)
Picture Archiving and Communication System (PACS) MHRA reference: 2016/006/028/601/014
Merge: iConnect Enterprise Archive
13 July 2016 (2016-067)
Picture Archiving and Communication System (PACS) MHRA reference: 2016/006/028/601/021
Merge: iConnect Enterprise Archive
13 July 2016 (2016-059)
Picture Archiving and Communication System (PACS) MHRA reference: 2016/006/028/601/013
Merge: iConnect Enterprise Archive
13 July 2016 (2016-062)
Picture Archiving and Communication System (PACS) MHRA reference: 2016/006/028/601/012
Merge: Merge PACS
13 July 2016 (2016-009)
Picture Archiving and Communication System (PACS) MHRA reference: 2016/006/028/601/008
Merge: Merge PACS
13 July 2016 (2016-012)
Picture Archiving and Communication System (PACS) MHRA reference: 2016/006/028/601/019
Merge: Merge PACS
13 July 2016 (2016-033)
Picture Archiving and Communication System (PACS) MHRA reference: 2016/006/028/601/018
Merge: Merge PACS
13 July 2016 (2016-010)
Picture Archiving and Communication System (PACS) MHRA reference: 2016/006/028/601/017
Merge: Merge PACS
13 July 2016 (2016-034)
Picture Archiving and Communication System (PACS) MHRA reference: 2016/006/028/601/016
Merge: Merge PACS
13 July 2016 (2016-051)
Picture Archiving and Communication System (PACS) MHRA reference: 2016/006/028/601/011
MoNo: ULTRASTOP pro med
June 2016
Endoscopes, flexible
MHRA reference: 2016/007/013/299/010
Newdeal: Large Qwix® Positioning screws
13 July 2016
Osteosynthesis, bone screws Model: 121530S, 121535S, 121540S,121545S, 121550S, 121555S, 121560S, 121565S, 121570S, 121575S, 121580S, 121740S, 121745S, 121750S, 121755S, 121760S, 121765S, 121770S, 121775S, 121780S, 121785S, 121790S, 121795S, 121800S, 121805S, 121810S, 121815S, 121820S
MHRA reference: 2016/007/022/299/015
Novus Scientific AB: TIGR Matrix Surgical Mesh
19 July 2016
Implants, non-active, abdominal & hernia mesh
Model: NSTM1015E, NSTM1520E, NSTM2030E
MHRA reference: 2016/007/025/701/001
Ortho Solutions: Foot Plating System
21 July 2016
Osteosynthesis, bone screws
Model: OS326835
MHRA reference: 2016/007/022/299/019
Philips: Ingenuity Core128
21 July 2016
Computed tomography Model: 728323
MHRA reference: 2014/004/008/081/044
Smith & Nephew: Sterile RENASYS™ Transparent Film RENASYS™ Dressing kits that contain the folded RENASYS™ Transparent Film
21 July 2016 (WR-2016-03)
Active wound management
MHRA reference: 2016/007/022/701/013
Smith & Nephew: WHIPKNOT Soft Tissue Cinch #5 Sutures
21 July 2016
Suture non absorbable MHRA reference: 2016/007/022/299/001
Siemens: Xprecia Stride Coagulation Analyzer
July 2016
Coagulation
MHRA reference: 2016/007/026/601/003
Siemens: ADVIA Chemistry XPT System
25 July 2016
IVDs, clinical chemistry
Model: SMN 10723034
MHRA reference: 2016/007/026/601/002
Siemens: AXIOM Artis; Artis zee; Artis Q/Q zen
27 June 2016
X Ray, fluoroscopy systems Model: various
MHRA reference: 2016/007/015/601/001
Siemens: Artis zee; verschiedene - various / verschiedene -various
15 February 2016
X Ray, fluoroscopy systems Model: Cardio/Angio System, systems with generator A100plus, Artis zeego systems mit Software VC21B
MHRA reference: 2016/003/014/292/011
Sorin Group: PLATINUM
27 July 2016
Implants, active, defibrillators
Model: PLATINIUM VR 1210, PLATINIUM DR 1510, PLATINIUM CRT-D 1711
PLATINIUM SonR CRT-D 1811, PLATINIUM VR 1240, PLATINIUM DR 1540, PLATINIUM CRT-D 1741, PLATINIUM SonR CRT-D 1841, PLATINUM
MHRA reference: 2016/007/028/299/001
The Binding Site: Optilite Analyser
15 July 2016
IVDs, immunology MHRA reference: 2015/005/007/601/006
Trinity Biotech: Captia™ Malaria EIA
19 July 2016
IVDs, bacteriology
MHRA reference: 2016/007/022/299/026