法规动态

Stryker reports some devices may suffer early battery loss, leading to power issues and coil detachment failure.

Stryker reports that some devices can suffer premature battery drain, leading to power failures, weak indicators, or coil detachment issues.

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.

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.

Health Canada warns that certain printer and modem access port connectors on Stryker LifePak R35 monitor‑defibrillators may not be fully seated during production.

Stryker discovered that some LifePak R-35 units may have printer and modem access port connectors not fully seated, potentially appearing flush or recessed.

Stryker reports the LP35 may not display the "CHECK RHYTHM / ECG Analysis Inconclusive" message under certain conditions, while shock advisories and therapy remain functional.

Health Canada reports Stryker’s LP35 may not display the “CHECK RHYTHM / ECG Analysis Inconclusive” message, though shock advisories and therapy remain unaffected.

Cardinal Health reports a recall of Stryker's StrykeFlow PS devices after multiple complaints of handpiece leakage during use.

Cardinal Health reports a Stryker recall of the StrykeFlow PS device due to multiple complaints of handpiece leakage during use.