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Novedades regulatorias de FDA, EMA, TGA y organismos globales

#Stryker ×

UPDATED
Actualizaciones regulatorias
24 sept 2026•1 min de lectura
Stryker alerts premature battery drain in certain devices
Stryker reports some devices may suffer early battery loss, leading to power issues and coil detachment failure.
UPDATED
Actualizaciones regulatorias
24 sept 2026•1 min de lectura
Stryker devices may experience premature battery drain, affecting operation
Stryker reports that some devices can suffer premature battery drain, leading to power failures, weak indicators, or coil detachment issues.
UPDATED
Actualizaciones regulatorias
10 sept 2026•1 min de lectura
Stryker T2 Alpha IMN Advanced Locking Screw Lot Mislabelled, 75 mm Instead of 57.5 mm
Health Canada alerts that a Stryker T2 Alpha IMN advanced locking screw lot is mislabeled, containing 75 mm screws rather than the specified 57.5 mm.
UPDATED
Actualizaciones regulatorias
10 sept 2026•1 min de lectura
Stryker Issues Labeling Alert for T2 Alpha IMN Advanced Locking Screw Lot
Stryker reports a labeling error in one lot of T2 Alpha IMN advanced locking screws, which contain 75 mm screws instead of the specified 57.5 mm.
UPDATED
Actualizaciones regulatorias
4 sept 2026•1 min de lectura
Health Canada Alert: Stryker LifePak R35 Connector Seating Issue
Health Canada warns that certain printer and modem access port connectors on Stryker LifePak R35 monitor‑defibrillators may not be fully seated during production.
UPDATED
Actualizaciones regulatorias
4 sept 2026•1 min de lectura
Stryker LifePak R-35 Monitor-Defibrillator May Have Improperly Seated Connectors
Stryker discovered that some LifePak R-35 units may have printer and modem access port connectors not fully seated, potentially appearing flush or recessed.
UPDATED
Actualizaciones regulatorias
2 sept 2026•1 min de lectura
Stryker LP35 Defibrillator Display Issue Identified
Stryker reports the LP35 may not display the "CHECK RHYTHM / ECG Analysis Inconclusive" message under certain conditions, while shock advisories and therapy remain functional.
UPDATED
Actualizaciones regulatorias
2 sept 2026•1 min de lectura
Stryker LP35 Defibrillator Fails to Show “Check Rhythm” Prompt
Health Canada reports Stryker’s LP35 may not display the “CHECK RHYTHM / ECG Analysis Inconclusive” message, though shock advisories and therapy remain unaffected.
UPDATED
Actualizaciones regulatorias
30 ago 2026•1 min de lectura
Stryker Issues Recall of StrykeFlow PS Handpieces Over Leakage Issues
Cardinal Health reports a recall of Stryker's StrykeFlow PS devices after multiple complaints of handpiece leakage during use.
UPDATED
Actualizaciones regulatorias
30 ago 2026•1 min de lectura
Stryker Issues Recall of StrykeFlow PS Handpiece Over Leak Complaints
Cardinal Health reports a Stryker recall of the StrykeFlow PS device due to multiple complaints of handpiece leakage during use.