Medications & Supplements High Severity Mandatory

Health Canada Recalls Carestation 850 Anesthesia Systems Over Shutdown Risk

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Health Canada has classified a Type II recall for the Carestation 850 and 850C anesthesia systems, manufactured by Datex-Ohmeda, Inc., after identifying a defect that can cause the devices to shut down unexpectedly. The recall, dated August 19, 2026 and published August 28, 2026, carries the identification number RA-82535.

The issue affects units used in hospitals and surgical facilities across the country. According to Health Canada, the anesthesia systems can experience an unexpected shutdown when AC mains power is disconnected or when AC mains power is lost during use, a scenario that could occur mid-procedure in an operating room.

Recalled Products at a Glance

The recall covers the Carestation 850 anesthesia system, identified by model or catalogue number 1012-9850-000. No specific lot or serial number range was listed for the affected units; Health Canada notes this field as ‘not applicable,’ meaning the issue applies broadly to devices under this model designation, including the related 850C variant referenced in the description of the issue.

  • Product: Carestation 850 (and 850C) anesthesia system
  • Model/catalogue number: 1012-9850-000
  • Manufacturer: Datex-Ohmeda, Inc., Madison, Wisconsin, United States
  • Recall class: Type II
  • Identification number: RA-82535

What Went Wrong?

The core problem lies in how the anesthesia system responds to a loss of AC mains power. Rather than transitioning smoothly, such as switching to battery backup or another failsafe mode, affected units can shut down unexpectedly when mains power is disconnected or interrupted. For a device that supports anesthesia delivery during surgery, an abrupt and unplanned shutdown raises obvious concerns for patient safety, since clinicians rely on continuous, predictable operation of the system throughout a procedure.

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Health Canada categorizes this as a Type II recall, a classification reserved for situations where a product may cause temporary or medically reversible health consequences, or where the probability of serious harm is considered remote. The listing does not report any confirmed injuries linked to the defect at the time of publication.

Who Should Be Concerned

This recall is directed at healthcare facilities and clinical staff rather than individual consumers, as Carestation 850 and 850C units are professional-grade anesthesia machines used in hospital and surgical settings. The audience for this alert is listed by Health Canada as healthcare professionals, meaning hospital biomedical engineering teams, anesthesiologists, and procurement staff overseeing this equipment should take note.

Facilities that have the model number 1012-9850-000 in service should treat this notice as relevant, regardless of when the unit was purchased, since no lot-specific limitation was provided.

What Should You Do?

Health Canada’s guidance for this recall is straightforward: facilities and staff who require additional information should contact the manufacturer directly. Datex-Ohmeda, Inc. is based at 3030 Ohmeda Drive, Madison, Wisconsin, and is responsible for coordinating any further guidance, inspection, or corrective action related to affected Carestation 850 and 850C units.

Hospitals operating this equipment may want to confirm with biomedical engineering staff whether their units fall under the affected model number and review internal protocols for responding to unexpected power interruptions during anesthesia delivery, until manufacturer guidance is received.

From the Agency

Health Canada’s public notice states plainly that the issue is an ‘unexpected shutdown of Carestation 850 and 850C anesthesia systems when AC mains power is disconnected or AC mains power is lost.’ The agency lists the recall under its medical devices category, within the anaesthesiology subcategory, and confirms the notice was last updated on August 28, 2026.

Consumers and healthcare providers can subscribe to Health Canada’s recall notification service for updates on this and future medical device alerts, or report separate health and safety concerns directly to the department.

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