Regulatory Updates

GE Healthcare reports that the CARESCAPE Central Station (CSCS) v3.0.x may not resume patient monitoring for at least three minutes after a system restart.

GE Healthcare reports that its CARESCAPE Central Station v3.0.x may fail to resume patient monitoring for at least three minutes after a system restart.

Health Canada reports that the UDI label for model p7924a13 incorrectly lists a 40‑inch surface, while the approved configuration is a 36‑inch surface, risking incompatible bed frame use.

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

Abiomed has issued a voluntary recall of all Automated Impella Controllers in Canada due to purge flag component failures that can affect device performance.

ICU Medical Canada is recalling IV sets with potential discoloration in the drip chamber; products remain usable per facility protocol.

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

ICU Medical Canada is recalling certain IV sets because discoloration may appear in the drip chamber, though they remain usable per protocol.

Cynosure Lutronic reports an adverse trend of spark and loud noise complaints causing patient burns during vascular treatments with the DermaV laser system.

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.

Health Canada identified sterile barrier integrity failures in Maquet's percutaneous insertion kit and dilator sets, affecting all PIK line products within shelf-life.

Draeger reports observed hose cracks in VentStar Resus Neo and Resuscitaire; no confirmed patient harm yet.