Arkon Anesthesia Delivery System with Arkon Software Version 2.70, Display Unit Assembly 650-1769-00…
Medical device recall Z-2589-2018. Published in FDA’s Enforcement Report on Aug 22, 2018.
- FDA Class I
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Aug 22, 2018. Copied from openFDA on Oct 20, 2026.
- Class I FDA’s most serious class (needs attention)
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 14 states named
- 328 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class I, the most serious of FDA’s three classes.
“Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.”
openFDA, in plain words, its enforcement report fields.
“Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
FDA’s rule, 21 CFR 7.3(m)(1), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Arkon Anesthesia Delivery System may go into a failed state (mechanical ventilation ceases) while the machine is in use or while idle.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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 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.
328, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI #: 10841522100017, Serial #: ARKN-000014 ARKN-000045 ARKN-000117 arkn-000248 ARKN-000003 ARKN-000004 ARKN-000012 ARKN-000013 ARKN-000039 ARKN-000040 ARKN-000044 ARKN-000047 ARKN-000048 ARKN-000049 ARKN-000259 ARKN-000260 ARKN-000334…
Every code shown here, 1,989 characters
UDI #: 10841522100017, Serial #: ARKN-000014 ARKN-000045 ARKN-000117 arkn-000248 ARKN-000003 ARKN-000004 ARKN-000012 ARKN-000013 ARKN-000039 ARKN-000040 ARKN-000044 ARKN-000047 ARKN-000048 ARKN-000049 ARKN-000259 ARKN-000260 ARKN-000334 ARKN-000425 arkn-000318 arkn-000321 ARKN-000120 ARKN-000380 ARKN-000381 ARKN-000382 ARKN-000383 ARKN-000384 ARKN-000385 ARKN-000386 arkn-000263 arkn-000264 ARKN-000288 arkn-000320 arkn-000231 arkn-000232 ARKN-000250 ARKN-000251 ARKN-000252 ARKN-000445 ARKN-000190 ARKN-000191 ARKN-000192 ARKN-000193 ARKN-000194 ARKN-000208 ARKN-000051 ARKN-000054 ARKN-000056 ARKN-000057 ARKN-000058 ARKN-000059 ARKN-000060 ARKN-000061 ARKN-000063 ARKN-000064 ARKN-000112 ARKN-000114 ARKN-000116 ARKN-000171 arkn-000242 arkn-000243 arkn-000244 ARKN-000062 ARKN-000071 ARKN-000072 ARKN-000073 ARKN-000074 ARKN-000075 ARKN-000076 ARKN-000077 ARKN-000078 ARKN-000037 ARKN-000066 ARKN-000067 ARKN-000132 ARKN-000133 ARKN-000134 ARKN-000144 ARKN-000186 ARKN-000187 ARKN-000188 ARKN-000189 ARKN-000196 ARKN-000197 ARKN-000198 ARKN-000199 ARKN-000200 ARKN-000201 ARKN-000202 ARKN-000203 ARKN-000204 ARKN-000205 ARKN-000206 ARKN-000207 ARKN-000209 ARKN-000210 ARKN-000211 ARKN-000212 ARKN-000213 ARKN-000214 ARKN-000215 ARKN-000216 ARKN-000217 ARKN-000220 ARKN-000221 ARKN-000222 arkn-000254 arkn-000261 ARKN-000262 ARKN-000278 ARKN-000279 ARKN-000283 ARKN-000286 ARKN-000294 ARKN-000300 ARKN-000301 ARKN-000302 ARKN-000303 ARKN-000304 ARKN-000305 arkn-000322 arkn-000323 arkn-000324 arkn-000325 arkn-000327 arkn-000328 ARKN-000332 ARKN-000333 ARKN-000335 ARKN-000336 ARKN-000337 ARKN-000338 ARKN-000341 ARKN-000342 ARKN-000344 ARKN-000345 ARKN-000387 ARKN-000388 ARKN-000389 ARKN-000390 ARKN-000391 ARKN-000392 ARKN-000393 ARKN-000394 ARKN-000395 ARKN-000396 ARKN-000399 ARKN-000401 ARKN-000402 ARKN-000403 ARKN-000404 ARKN-000405 ARKN-000406 ARKN-000407 ARKN-000408 ARKN-000409 ARKN-000410 ARKN-000411 ARKN-000412 ARKN-000413 ARKN-000466 ARKN-000119 ARKN-000123 ARKN-000041…
FDA’s list runs to 3,968 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide Distribution: U.S (nationwide) to states of.: LA, NE, CO, WY, MT, NM, IN, ME, NY, IL, MA, TX, PA, PR; and countries (OUS) of: PERU BOLIVIA, PANAMA, MALAYSIA, POLAND, IRELAND, MOROCCO, MEXICO, CANADA, UNITED KINGDOM, FRANCE, and CHINA, ECUADOR.
The states and territories these words name
14 states and territories.
Every one of them
- Colorado
- Illinois
- Indiana
- Louisiana
- Massachusetts
- Maine
- Montana
- Nebraska
- New Mexico
- New York
- Pennsylvania
- Puerto Rico
- Texas
- Wyoming
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jul 11, 2018.
- FDA classified it on Aug 10, 2018.
- FDA’s Enforcement Report published it on Aug 22, 2018.
- FDA terminated it on Mar 20, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Spacelabs Healthcare, Ltd., of Hertford, United Kingdom.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 3,968 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.