FDAJuly 11, 2018device

Arkon Anesthesia Delivery System with Arkon Software Version 2.70, Display Unit Assembly 650-1769-00 installed, and Model #: 99999. This system includes a ventilator. The Spacelabs Arkon Anesthesia Workstation is intended for use in the hospital environment and operating room. It may be used for ...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Arkon Anesthesia Delivery System may go into a failed state (mechanical ventilation ceases) while the machine is in use or while idle.

What to do

FDA enforcement status: Terminated

Brands named

spacelabs healthcarespacelabs

UPCs

10841522100017

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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FDABrand Name: Spacelabs Ultraview SL Command Module Product Name: SL Command Module Model/Catalog Number: 91496 Software Version: N/A Product Description: The Command Module (91496) is the core of the Spacelabs patient monitoring system, providing the processing power for all basic physiologic para...2026-03-26
FDAGE Healthcare Omnipaque (iohexol) Injection, 300 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1413-63.2026-03-24
FDAGE Healthcare Omnipaque (iohexol) Injection, 350 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1414-91.2026-03-24

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