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Datex-Ohmeda anaesthesia machines recalled in Canada over possible under-delivery of agent

Health Canada has listed a Type II recall of Carestation 850 and 850c systems, but the notice gives no cause, incident data or remedy.

10 Nov 2026 · Health Canada · Regulator

Datex-Ohmeda, Inc. has recalled its Carestation 850 and 850c anaesthesia systems in Canada because the machines may deliver less anaesthetic agent than the clinician has set. Health Canada published the notice on 10 November 2026, under reference RA-82934. The manufacturer's own recall date is 28 October 2026.

The notice contains nothing on commercial exposure. It gives no count of units in the field, no cost estimate, no information on whether replacement or repair capacity is available, and no indication that sales or shipments have been halted. Any effect on the manufacturer's revenue or on hospital purchasing therefore cannot be gauged from the filing.

Health Canada categorises the entry as a performance problem in anaesthesiology devices and addresses it to healthcare professionals. The listed product is Carestation 850, model number 1012-9850-000. It states that more than 10 lot or serial numbers are affected but does not name them, leaving the full list with Datex-Ohmeda, whose address is given as Madison, Wisconsin. Readers are told only to approach the company for more information.

The notice does not explain the fault, report any incidents or injuries, or describe a fix such as a repair or software change. By way of context, Health Canada applies the Type II label to recalls where use of a product may cause temporary or medically reversible adverse effects, or where the chance of serious harm is remote. The notice does not mention any other country or regulator.

Why it matters

  • The affected serial numbers are held by the manufacturer, so hospitals and distributors cannot establish their exposure from the public notice alone.
  • With no root cause or corrective action published, the cost and duration of any remediation remain unknown.
  • The Health Canada entry says nothing about other markets, so whether regulators elsewhere issue similar notices is an open question.

Official record: Health Canada ↗

Written by CompePharma's editorial system from the official record. AI-assisted; check the source before acting. Not investment advice.

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