Regulatorische Updates

ICCA's J.06.01 and J.06.02 releases warn that auto‑charting of infusion data can produce incorrect intake, output and net body balance values for units using automatic charting settings.

Beckman Coulter reports a software flaw in DxC 500i and DxC 500 AU clinical chemistry analyzers that can revert user-selected units to defaults when plasma samples are tested, without warning.

Philips reports a software fault in MR systems (versions R5 & R11) that can freeze the system during image reconstruction, requiring a restart.

Gore discovered some VIABAHN® devices were processed on equipment outside the validated range, potentially causing incorrect distal tip bonding.

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

Cynosure Lutronic reports patient burn incidents linked to spark and loud noise during DermaV laser vascular procedures.

Health Canada reports failures in sterile barrier integrity testing for Maquet percutaneous insertion kits, limiting the FSCA to all PIK line products within shelf‑life.

Draeger reports users have found visible hose cracks in VentStar® Resus Neo and Resuscitaire devices before use; no health impacts reported but risk cannot be excluded.

Health Canada warns that certain Aisys™ Carestation™ and Aisys™ CS² anesthesia systems with specific electronic gas mixer assemblies may automatically switch to Alternate O₂ control.