Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. RAL Diagnostics, NC 23.012, MCDh 1

   Trois signalements concordants ont été signalés sur ces lots de produits, des non-conformités internes ont été ouvertes et des ...

   Waarschuwing | 08-02-2023

2. Siemens Healthcare Diagnostics Inc, ACHC 23-01, Atellica CH LDL Cholesterol Direct DLDL reagents Total Protein II TP reagents Triglycerides Trig reagents Triglycerides_2 Trig_2 reagents

   Siemens Healthcare Diagnostics Inc. has confirmed through customer complaints the potential for reagent carryover impacting ...

   Waarschuwing | 08-02-2023

3. Roche Diagnostics GmbH, SBN-RDS-CoreLab-2023-001, Elecsys Troponin T hs Elecsys Troponin T hs STAT

   During internal studies with the Elecsys Troponin T hs (high sensitive) / Elecsys Troponin T hs STAT assay, discrepant elevated ...

   Waarschuwing | 06-02-2023

4. Miele & Cie. KG, FSN-INC000000545062, Steelco PWD 8626 / Steelco PWD 8628

   Met deze brief willen wij u informeren over een mogelijk veiligheidsprobleem met betrekking tot de intelligente programmakeuze. ...

   Waarschuwing | 02-02-2023

5. Drägerwerk AG & Co. KGaA, FSN-PR 126026, Flex ventilation hoses

   Due to a deviation in the manufacturing process, components of the hose material remained as particles inside the hoses. Our ...

   Waarschuwing | 30-01-2023

6. Ivor Shaw Ltd t/a Pennine Healthcare, FSN-PHFSN 2023-1, Link Yankauer Sets and Suction Connecting Tubing

   Pennine has received two customer complaints related to sterile barrier (pouch) breach. The pouches were found to be open before ...

   Waarschuwing | 26-01-2023

7. Implantcast GmbH, FSN-FSCA_22002, MUTARS® HD coupling

   The reason for this product recall is that four serious incidents were fed back to us in which the MUTARS® HD coupling failed.

   Waarschuwing | 26-01-2023

8. PlanerLimited, FSN-1216677-07-21-2022-002-R, Humidifier Bottle and Syringe filter kit for BT37

   CooperSurgical has sent a recall notification to all affected customers. The products are being recalled due to a repackaging ...

   Waarschuwing | 26-01-2023

9. Balanced Body, Inc., FSN-FSCA-001-REFORMER, Studio Reformer

   Balanced Body has determined that when a user performs Reformer exercises in a standing or high kneeling position on the carriage ...

   Waarschuwing | 26-01-2023

10. Metronic' Vanta™ Artsenprogrammeerapplicatie (CP App) A71200 (v2.0.2465) FA1260 FA1266 en FA1292

    In July 2022, Medtronic notified customers of a potential communication issue in which the Vanta Clinician Programmer Application ...

    Waarschuwing | 19-01-2023