Aisys CS2 Anesthesia System. Sold under the following product names: AISYS, AISYS 10.X TO 11.X UPGRADE KIT DUTCH, AISYS

FDA device recall Z-0412-2019 · posted 2018-11-09 · Terminated

Recall details

Recalling firm

GE Healthcare, LLC

Reason for recall

Upgraded Aisys anesthesia devices and Aisys CS2 anesthesia devices with PSVPro Spontaneous Breathing Modes do not provide the PSVPro ventilation mode feature of transitioning to SIMV PCV backup ventilation mode. PSVPro Spontaneous Breathing Modes do not provide the feature of transitioning to SIMV PCV backup ventilation mode for a patient who stops spontaneous breathing if the PSVPro ventilation mode is in use prior to the clinician starting the Cycling Procedure.

Action taken

GE Healthcare notified customers on about 09/27/2018 via "URGENT MEDICAL DEVICE CORRECTION" letter. The letter informed customers that they could continue to use the anesthesia device. The issue can only occur if the patient stops spontaneous breathing in PSVPro ventilation mode after completion of lung recruitment breaths. Stopping the Cycling Procedure resolves the issue. Continue to monitor patient as is normal for Apnea. A GE Healthcare representative will contact each customer to arrange for the correction. Questions or concerns can be directed to GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

Root cause

Software design

Status

Terminated

Product code

BSZ

Quantity affected

4,207 units total

Distribution

Worldwide distribution - US nationwide in the states of CA, CO, DC, FL, GA, HI, IA, IL, IN, KY, LA, ,MA, MD, MI, MN, MO, MT, NC, NE, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV. Countri

Date initiated

2018-09-27

Date posted

2018-11-09

Date terminated

2021-04-12

Location

Waukesha, WI

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