Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported July 31, 2013
Spacelabs ARKON Anesthesia Workstation. Spacelabs ARKON Anesthesia Workstation 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.
Spacelabs ARKON Anesthesia System is recalled due to software defect. The System Status Computer may incorrectly determine that a communication error has occurred. If this situat…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Del Mar Reynolds Medical, Ltd. recalled Spacelabs ARKON Anesthesia Workstation. Spacelabs ARKON Anesthesia Workstation may be… - a moderate-severity action.
Spacelabs ARKON Anesthesia Workstation. Spacelabs ARKON Anesthesia Workstation may be… was recalled by Del Mar Reynolds Medical, Ltd. in July 31, 2013. Reason: Spacelabs ARKON Anesthesia System is recalled due to software defect. The System Status Computer may incorre…. Check the official notice for the remedy. Verify recall #Z-1771-2013 with the FDA Devices before acting.
The recall
Del Mar Reynolds Medical, Ltd. issued this moderate-severity FDA Devices recall-Spacelabs ARKON Anesthesia System is recalled due to software defect. The System Status Computer may incorre….
- Moderate
- severity level
- 9 units
- affected scope
- Class II
- classification
- July 31, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1771-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1771-2013) was formally reported on July 31, 2013, with the manufacturer initiating the action on June 7, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Del Mar Reynolds Medical, Ltd. is listed as the recalling firm, operating out of Hertford, N/A. Federal records list the affected scope as 9 units (4 in the US and 5 outside US).
The documented reason for this recall is: Spacelabs ARKON Anesthesia System is recalled due to software defect. The System Status Computer may incorrectly determine that a communication error has occurred. If this situation occurs, a buzzer will activate and a… Distribution data in the federal record shows the product reached: Worldwide Distribution - USA including South Carolina and internationally to Canada and Great Britian.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
9 units (4 in the US and 5 outside US)
Related Recalls
6
3 from same agency
Product description
Spacelabs ARKON Anesthesia Workstation. Spacelabs ARKON Anesthesia Workstation 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.
Reason for recall
Spacelabs ARKON Anesthesia System is recalled due to software defect. The System Status Computer may incorrectly determine that a communication error has occurred. If this situation occurs, a buzzer will activate and a yellow triangle will be displayed on the System Status Computer screen that alerts the user of this error.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1771-2013 |
| Date reported | July 31, 2013 |
| Date initiated | June 7, 2013 |
| Recalling firm | Del Mar Reynolds Medical, Ltd. |
| Firm location | Hertford, N/A |
| Affected scope | 9 units (4 in the US and 5 outside US) |
| Distribution | Worldwide Distribution - USA including South Carolina and internationally to Canada and Great Britian. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1771-2013) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Spacelabs ARKON Anesthesia Workstation. Spacelabs ARKON Anesthesia Workstation 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.. Recalled by Del Mar Reynolds Medical, Ltd.. Units affected: 9 units (4 in the US and 5 outside US).
Why was this product recalled? ▼
Spacelabs ARKON Anesthesia System is recalled due to software defect. The System Status Computer may incorrectly determine that a communication error has occurred. If this situation occurs, a buzzer will activate and a yellow triangle will be displayed on the System Status Computer screen that alerts the user of this error.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 31, 2013. Severity: Moderate. Recall number: Z-1771-2013.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA including South Carolina and internationally to Canada and Great Britian..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1771-2013) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported July 31, 2013. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.