Food, drugs, devices › GE Medical Systems, LLC
Device recall: GE Healthcare, Aisys CS2 anesthesia..
FDA enforcement event 73383 is a device recall by GE Medical Systems, LLC of Waukesha, WI, initiated 17 Feb 2016 and classified Class II, with 2 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,232 device enforcement events initiated in 2016 carry the same class.
Status: Terminated, terminated 4 Sep 2018. Initiation: voluntary: firm initiated. GE Medical Systems, LLC has 42 enforcement events on this register, with a median of 3 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
GE Medical Systems, LLC, Waukesha, WI.
Reason for recall
"GE Healthcare has recently become aware of a potential safety issue involving a momentary, self-correcting anesthetic agent bolus when using 21% oxygen on all Aisys CS2 and upgraded Aisys anesthesia devices."
Distribution
"US: AL, AZ, AR, CA, CO, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MO, NE, NV, NJ, NY, NC, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI. OUS: ARGENTINA, AUSTRALIA,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1381-2016 | GE Healthcare, Aisys CS2 anesthesia.. | 5496 | Class II | Terminated | 20 Apr 2016 |
| Z-1382-2016 | GE Healthcare, Aisys Carestation. | 1294 | Class II | Terminated | 20 Apr 2016 |
Context
Other enforcement events for GE Medical Systems, LLC
All 42 events for GE Medical Systems, LLC
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "GE Healthcare has recently become aware of a potential safety issue involving a momentary, self-correcting anesthetic agent bolus when using 21% oxygen on all Aisys CS2 and upgraded Aisys anesthesia devices."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US: AL, AZ, AR, CA, CO, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MO, NE, NV, NJ, NY, NC, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI. OUS: ARGENTINA, AUSTRALIA,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 4 Sep 2018. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.