Field safety notices - 15 to 19 June 2015
List of field safety notices (FSNs) from medical device manufacturers from 15 to 19 June 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
.3M ESPE Dental Products: 3M ESPE Lava Ultimate
3005174370 06022015-001-C-GB
Dental materials
MHRA reference:
ArthroCare Corporation: PROCISE EZ VIEW
10 June 2015
Surgical, diathermy
MHRA reference:
Bedfont Scientific: NOxBOX
8 June 2015
Nitric oxide delivery system
MHRA reference:
bioMerieux: Etest庐 Cefotaxime CT 256
15 June 2015
IVDs, bacteriology
MHRA reference:
Biomet: Oxford femoral drill guide lateral IM adapter
11 June 2015
Surgical instruments, implant
MHRA reference:
Boston Scientific: Clearsign II amplifier
91046622-FA
Diagnostic measurement and monitoring
Model: CLEARSIGN鈩� II amplifier for LABSYSTEM鈩� PRO EP recording system
MHRA reference:
Cook Incorporated
28 May 2015
Surgical instruments, minimal access
Model: Cook LapSac庐 surgical tissue pouch
MHRA reference:
Curefab Technologies: Curefab CS
FT-2248
Ultrasound, imaging
MHRA reference:
Depuy Synthes: Guide wire 2.8mm, L 180mm w/ thread
11 June 2015
Surgical instruments, implant
Model: 03.007.020
MHRA reference:
Dermaroller: Transdermal needle roller, single-use
7 May 2015
Device description: Surgical devices, non-powered
Model: Dermaroller MC: MC415, MC905, MC915
MHRA reference:
Handicare: ReTurnBelt wipeable
15 June 2015
Moving and handling
Model: 6133, 6134, 6135, 6136
MHRA reference:
Labor Dr. Merk & Kollegen: Hemolytic system
13 April 2015
IVDs, clinical chemistry
Model: HS-020, HS-023, HS-050, HS-053, HS-100, HS-103
MHRA reference:
MAQUET: MAGNUS Hybrid OR table column
21 May 2015
Operating table
Model: 1180.01B2
MHRA reference:
Medtronic: DLP庐 femoral arterial cannula and DLP庐 femoral cannula and insertion kits
June 2015
Vascular cannula and catheters
Model: 57414, 57417, 57421, Kit 96017, 96021
MHRA reference:
Merit Medical Systems: Merit prelude sheath introducer
Prelude庐 Sheath Introducer Recall
Vascular cannula/catheter accessories
Model: PRO-6F-11-038, Lot H767887
MHRA reference:
Philips Medical Systems DMC: MobileDiagnost wDR
19 May 2015
Direct digital radiography
Model: 712001/712002
MHRA reference:
PTW Freiburg: UNIDOS webline
11 May 2015
Radiotherapy planning and verification systems
Model: T10021, T10022, T10023
MHRA reference:
Roche Diagnostics: S3 fluid pack A, SS2 fluid pack
12 June 2015
IVDs, extra laboratory testing
MHRA reference:
Siemens: Cios Alpha; 10308191
Siemens - UI XP015-15-S and UI XP018-15-S
X-ray, mobiles
MHRA reference:
Siemens Healthcare Diagnostics: IMMULITE and 1000 sample cup holder set / IMMULITE 2000 microsampling tube holder set
June 2015
IVDs, clinical chemistry
Model: SMNs 10385360 / 10385319 /10385209
MHRA reference:
Stryker Leibinger Freiburg: Navigation System II-Cart
18 May 2015
Surgical navigation system
MHRA reference:
Zethon: REM-DF02, REM-DF04, REM-DF06, REM-DF07 - all batches
16 June 2015
Pacemakers, external
MHRA reference:
Zethon: REM-101, REM-101-D, REM-101-SP, REM-102, REM-102-D, REM-103, REM-103-D, REM-104, REM-104-D, REM-105, REM-105-D, - all batches
8 June 2015
Surgical, diathermy
MHRA reference: