My HPRA: Register

Summary of Field Safety Notices - October 2022

Notice type: 3rd Party Publications

Date: 02/11/2022

  

Further Information:
Abbott
Alinity m System
Advice regarding a software upgrade. HPRA Ref: V53038


Acutronic Medical Systems AG
fabianTM HFO, fabianTM +nCPAP evolution, and fabianTM Therapy evolution
Advice regarding a software upgrade. HPRA Ref: V47032


Armstrong Medical Ltd
Resuscitation Set - Mapleson C System with APL Valve
Advice regarding a device removal. HPRA Ref: V52812


Baxter
Prismaflex Sets (HF1000 set, HF1400 set, HF20 set, M100 set, M150 set, M60 set, ST100 set, ST150 set, ST60 set)
Advice regarding changes/updates made to instructions for use. HPRA Ref: V52734


Biohit Oyj
BIOHIT ColonView quick test FSN 1
BIOHIT ColonView quick test FSN Addendum
Advice regarding a device removal. HPRA Ref: V52969


Boston Scientific Corporation
ORISE™ Gel Submucosal Lifting Agent
Advice regarding changes/updates made to instructions for use. HPRA Ref: V52801


DiaMed GmbH - Cressier
IH-500
Advice regarding a software upgrade. HPRA Ref: V52749


Edwards Lifesciences
Fogarty Arterial Embolectomy Catheters, Fogarty Fortis Arterial Embolectomy Catheters, Fogarty Biliary Balloon Probes
Advice regarding a device removal. HPRA Ref: V52772


Fannin
GC Sensitivity Test Medium
Advice regarding the use of the device. HPRA Ref: V52396


GCE sro G
CE Combi Valve
Advice regarding a device modification. HPRA Ref: V52962


Getinge
Getinge ED-FLOW AER, Getinge ED-FLOW SD AER
Advice regarding a device modification. HPRA Ref: V53162


Hill-Rom S.A.S.
Hill-Rom 900, Ampera, Centuris Pro
Advice regarding the use of the device. HPRA Ref: V53034


Insulet Corporation
Omnipod DASH® Personal Diabetes Manager (PDM)
Advice regarding a software upgrade. HPRA Ref: V52936


LOWTeq GmbH
All versions of LOWTeqpdms
Advice regarding a software upgrade. HPRA Ref: V53114


Randox
Randox Serology I Positive Control
Advice regarding changes/updates made to instructions for use. HPRA Ref: V52209


Regen labs
Regen lab kits
Advice regarding a device removal. HPRA Ref: V52326


Roche
Elecsys CA 19-9
Advice regarding the use of the device. HPRA Ref: V42751


Smartbox
Talk Pad Communication Aid - 8, 10, and 13
Advice regarding a device modification. HPRA Ref: V53019


Tracoe
TRACOE Tracheostomy Tubes: TRACOE vario P-Tracheostomy Tube, TRACOE experc Set vario, TRACOE twist plus P-Tracheostomy Tube, TRACOE experc Set twist plus
Advice regarding a device removal. HPRA Ref: V53113


Waldemar Link GmbH & Co. KG
Endo-Model-M & Endo-Model SL Tibial Components
Advice regarding the use of the device. HPRA Ref: V51594
 

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