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Summary of Field Safety Notices - November 2014
Notice type:
3rd Party Publications
Date:
02/12/2014
Further Information:
3M Deutschland GmbH
3M™ RelyX™ Temp E NP
Advice regarding a device removal. HPRA Ref: V22506
Advanced Sterilization Products Inc.
STERRAD 50, STERRAD 100S, STERRAD 200, STERRAD 100NX and STERRAD NX System Cassettes
Advice regarding the use of the device. HPRA Ref: V22633
AMS
AdVance™ XP Male Sling Systems
Advice regarding a device removal. HPRA Ref: V22337
Baxter Healthcare
HomeChoice Automated PD System and HomeChoice PRO Automated PD System
FSN 1
HomeChoice Automated PD System and HomeChoice PRO Automated PD System
FSN 2
Advice regarding changes/updates made to instructions for use. HPRA Ref: V22517
BBraun Medical Limited
Dialog+
Advice regarding the use of the device. HPRA Ref: V22577
Cardiac Pacemaker Inc. (Boston Scientific Limited)
AUTOGEN CRT-D & AUTOGEN DR ICD
Advice regarding a software upgrade. HPRA Ref: V22578
Clongene Biotech Co. Limited
Clungene hCG Pregnancy Test
Advice regarding changes/updates made to instructions for use. HPRA Ref: V22095
Cromptoms Healthcare
Patient transfer sheet Item code: JC100
Advice regarding the use of the device. HPRA Ref: V22481
DePuy Synthes
Drill Bit 0 2.0mm drilling depth 14mm, 3-flute
Advice regarding a device removal. HPRA Ref: V22526
DePuy Synthes
ATTUNE® INTUITION™ IMPACTION HANDLE AND IMPACTORS
Advice regarding the use of the device. HPRA Ref: V22666
DiaMed GmbH
IH-1000
Advice regarding a software upgrade. HPRA Ref: V22501
DiaSorin
LIAISON Borrelia IgG
Advice regarding a device removal. HPRA Ref: V22591
Galt Medical Corp
Galt VTI Valved Tearaway Introducer
Advice regarding a device removal. HPRA Ref: V22374
Global Components Medical Limited
Eye Patched relating to TIVA sets
Advice regarding changes/updates made to instructions for use. HPRA Ref: V20614
Heinen + Loewenstein
LeoniPlus ventilator
Advice regarding the use of the device. HPRA Ref: V22530
HemoCue
HemoCue Glucose 201 Microcuvettes
Advice regarding a device removal. HPRA Ref: V22512
Institut Straumann AG
040.447S Drill set long, drill stop compatible for D 4.8mm Implant
Advice regarding a device removal. HPRA Ref: V22483
Invacare
Invacare Perfect O2 and Platinum Concentrator
Advice regarding a device modification. HPRA Ref: V22601
Medtronic
EnliteTM Glucose Sensor
Advice regarding a device removal. HPRA Ref: V22468
Merck Serono
Merck Serono pH Indicator Strips 0-6.0, Merck Serono pH Indicator Strips 2.0-9.0
Advice regarding changes/updates made to instructions for use. HPRA Ref: V20596
Nal Von Minden GmbH
Saliva Sample Collection Device Drug-Screen-Multi 6GA/6GC/6GD
Advice regarding the use of the device. HPRA Ref: V22460
Philips
Gel-E Donut and Squishon 2
Advice regarding a device removal. HPRA Ref: V22518
Philips Healthcare
BrightView SPECT, BrighView X and BrightView XCT
Advice regarding a software upgrade. HPRA Ref: V19773
Philips Healthcare
BrightView XCT
Advice regarding a software upgrade. HPRA Ref: V22538
Philips Medical Systems
IntelliSpace Critical Care & Anesthesia
Advice regarding a software upgrade. HPRA Ref: V22604
Siemens Healthcare Diagnostics
IMMULITE Calcitonin Control Module
Advice regarding changes/updates made to instructions for use. HPRA Ref: V22520
Stryker Orthopaedics
Triathlon Tibial Alignment Ankle Clamp EM
Advice regarding the use of the device. HPRA Ref: V18480
Tosoh Europe NV
Automated Glycohemoglobin Analyzers
Advice regarding the use of the device. HPRA Ref: V22396
X-Bolt Orthopaedics
Guidewire Measuring Ruler
Advice regarding a device removal. HPRA Ref: V22507
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Date Printed: 20/05/2024