Arkon Anesthesia Delivery System, Model 99999, and software… recallZ-0072-2018 · Spacelabs Healthcare, Ltd. · initiated Oct 11, 2017
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Spacelabs Healthcare, Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Arkon Anesthesia Workstation, with software version 2.61, experienced failure in mechanical ventilation, oxygen and anesthetic gas delivery, with concurrent failure of the display unit that resulted in a blank screen without audible or visible alarms.
FDA root cause category: Software design
What the company is doing
Spacelabs Healthcare sent an Urgent Medical Device Correction letter dated October 24, 2017. The letter identified the affected product problem and actions to be taken. For questions call 1-800-522-7025 and select 4 for Technical Support.
Recall details
- Recall number
- Z-0072-2018
- Status
- Terminated
- Initiated by the company
- Oct 11, 2017
- Posted by the FDA
- Nov 21, 2017
- Recalling firm
- Spacelabs Healthcare, Ltd.
- Quantity
- 110 units
- Product code
- BSZ
- FDA submissions
- K113051
- Distribution
- Nationwide Distribution to the states of NM, WY, FL, NC, MS, CO, CT, ME, and AL.
Product description
Arkon Anesthesia Delivery System, Model 99999, and software version 2.61 and upgrade kit 050-9043-00 Rev G. The Spacelabs Arkon Anesthesia Workstation is intended for use in the hospital environment and operating room. It may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer. The device is intended for use only by a suitably qualified physician
Code information (models, lots, serial numbers)
UDI: 10841522100017
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- ArkonSpacelabs Healthcare (Washington), Inc · Gas-Machine, Anesthesia2 recalls0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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