Product Wiki · Recalls · Health Canada — Medical Devices

Zeus IE Anesthesia Workstation (2019-03-11) — recall 59309

Health Canada — Medical Devices · Canada · 2019-04-05 · Type II

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
Health Canada — Medical Devices
Recall identifier
59309
Date of alert
2019-04-05
Country / jurisdiction
Canada
Authority classification
Type II
Notice type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Cases have been reported where the gas measurement of Zeus IE Anesthesia workstations became inactive. Draeger analysis revealed that the deactivations were caused by a too strict supervision of the sample gas pumps which are used in the gas measurement modules. As the characteristic of the pump changes with their usage time, the supervision system deactivates the gas measurement and a corresponding alarm message appears. Consequently, the probability of a gas measurement deactivation is correlated with the total usage time of the sample gas pumps. Long-term tests clearly indicate that the gas measurement is reliable for approximately 7 months assuming an average runtime of 84 hours per week. From that point on the probability of a deactivation increases beyond initial estimations.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/zeus-ie-anesthesia-workstation

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

Related

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.