GE Healthcare, LLC: Touchscreen display kit. Sold under the following product names: TOUCHSCREEN DISPLAY KIT 11.X ENGLISH FOR USA, TOUCHSCREEN DISPLAY KIT 11.X ENGLISH, TOUCHSCREEN DISPLAY KIT 11.X GERMAN, TOUCHSCREEN DISPLAY KIT 11.X DUTCH, TOUCHSCREEN DISPLAY KIT 11.X FRENCH, TOUCHSCREEN DISPLAY KIT 11.X DANISH, TOUCHSCREEN DISPLAY KIT 11.X ESTONIAN, TOUCHSCREEN DISPLAY KIT 11.X ITALIAN, TOUCHSCREEN DISPLAY KIT 11.X NORWEGIAN. Product Usage: The GE Datex-Ohmeda Aisys Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The device is intended for volume or pressure control ventilation. The Aisys is not suitable for use in a MRI environment.

Recall number

Z-0413-2019

Recalling firm

GE Healthcare, LLC

Product

Touchscreen display kit. Sold under the following product names: TOUCHSCREEN DISPLAY KIT 11.X ENGLISH FOR USA, TOUCHSCREEN DISPLAY KIT 11.X ENGLISH, TOUCHSCREEN DISPLAY KIT 11.X GERMAN, TOUCHSCREEN DISPLAY KIT 11.X DUTCH, TOUCHSCREEN DISPLAY KIT 11.X FRENCH, TOUCHSCREEN DISPLAY KIT 11.X DANISH, TOUCHSCREEN DISPLAY KIT 11.X ESTONIAN, TOUCHSCREEN DISPLAY KIT 11.X ITALIAN, TOUCHSCREEN DISPLAY KIT 11.X NORWEGIAN. Product Usage: The GE Datex-Ohmeda Aisys Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The device is intended for volume or pressure control ventilation. The Aisys is not suitable for use in a MRI environment.

Status

Terminated

Initiated

2018-09-27

Posted

2018-11-09

Terminated

2021-04-12

Reason

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.

Root cause

Software design

Action

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.

Quantity

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. Countries of Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea (Republic of), Kuwait, Macedonia, Mexico, Netherlands, New Zealand, Nigeria, Norway, Peru, Portugal, Qatar, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Vietnam.

Lot, serial or model codes

Model Number, UDI Number, (Serial Number):  2097673-001-US (4651698-1); 2097673-001-US (4651698-3); 2097673-001-US (4651698-4); 2097673-001-US (4651726-1); 2097673-001-US (4652206-1); 2097673-001-US (4652206-2); 2097673-001-US (4649618-1); 2097673-001-US (4649618-2); 2097673-001-US (4649618-3); 2097673-001-US (4649618-4); 2097673-001-US (4649618-5); 2097673-001-US (4653227-1); 2097673-001-US (4653227-2); 2097673-001-US (4653227-3); 2097673-001-US (5474296-1); 2097673-001-US (4652587-1); 2097673-001-US (4652587-2); 2097673-001-US (4652587-3); 2097673-001-US (4652587-4); 2097673-001-US (4652587-5); 2097673-001-US (4652587-6); 2097673-001-US (4632861-1); 2097673-001-US (4632861-2); 2097673-001-US (4632861-3); 2097673-001-US (4644953-1); 2097673-001 (5463757-1); 2097673-001 (5467309-16); 2097673-001 (5471699-1); 2097673-001 (5471699-2); 2097673-001 (5471699-3); 2097673-001 (5475515-1); 2097673-001 (5475515-2); 2097673-001 (5475516-1); 2097673-001 (5475516-10); 2097673-001 (5475516-2); 2097673-001 (5475516-3); 2097673-001 (5475516-4); 2097673-001 (5475516-5); 2097673-001 (5475516-6); 2097673-001 (5475516-7); 2097673-001 (5475516-8); 2097673-001 (5475516-9); 2097673-001 (5475528-1); 2097673-001 (5475528-10); 2097673-001 (5475528-11); 2097673-001 (5475528-12); 2097673-001 (5475528-13); 2097673-001 (5475528-14); 2097673-001 (5475528-15); 2097673-001 (5475528-16); 2097673-001 (5475528-17); 2097673-001 (5475528-18); 097673-001 (5475528-19); 2097673-001 (5475528-2); 2097673-001 (5475528-3); 2097673-001 (5475528-4); 2097673-001 (5475528-5); 2097673-001 (5475528-6); 2097673-001 (5475528-7); 2097673-001 (5475528-8); 2097673-001 (5475528-9); 2097673-001 (5481650-1); 2097673-001 (5481650-10); 2097673-001 (5481650-2); 2097673-001 (5481650-3); 097673-001 (5481650-4); 2097673-001 (5481650-5); 2097673-001 (5481650-6); 2097673-001 (5481650-7); 2097673-001 (5481650-8); 2097673-001 (5481650-9); 2097673-001 (5471701-1); 2097673-001 (5471701-2); 2097673-001 (5471702-1); 2097673-001 (5472013-1); 2097673-001 (5472013-10); 097673-001 (5472013-12); 2097673-001 (5472013-14); 2097673-001 (5472013-15); 2097673-001 (5472013-16); 2097673-001 (5472013-17); 2097673-001 (5472013-18); 2097673-001 (5472013-3); 2097673-001 (5472013-4); 2097673-001 (5472013-5); 2097673-001 (5472013-6); 2097673-001 (5472013-7); 2097673-001 (5472013-8); 2097673-001 (5463631-1); 2097673-001 (5463631-2); 2097673-001 (5466892-1); 2097673-001 (5466892-10); 2097673-001 (5466892-2); 2097673-001 (5466892-3); 2097673-001 (5466892-4); 2097673-001 (5466892-5); 2097673-001 (5466892-6); 2097673-001 (5466892-7); 2097673-001 (5466892-8); 2097673-001 (5466892-9); 2097673-DE (5480919-1); 2097673-NL (5473301-1); 2097673-NL (5473301-2); 2097673-NL (5473301-3); 2097673-NL (5473301-4); 2097673-NL (5473301-5); 2097673-NL (5473301-6); 2097673-FR (5481162-1); 2097673-NL (5481369-1); 2097673-NL (5481369-2); 2097673-NL (5481369-3); 2097673-NL (5481369-4); 2097673-NL (5481369-5); 2097673-NL (5481369-6); 2097673-NL (5481369-7); 2097673-NL (5481369-8); 2097673-NL (5481369-9); 2097673-001 (5462738-1); 2097673-001 (5462738-2); 2097673-FR (5475371-1); 2097673-FR (5475371-2); 2097673-FR (5475371-3); 2097673-FR (5475371-4); 2097673-FR (5475371-5); 2097673-FR (5479900-1); 2097673-DA (5453900-1); 2097673-ET (5461749-1); 2097673-FR (5481462-1); 2097673-FR (5481462-2); 2097673-FR (5481462-3); 2097673-FR (5481462-4); 2097673-FR (5481462-5); 2097673-FR (5481462-6); 2097673-FR (5481462-7); 2097673-FR (5481462-8); 2097673-FR (5481462-9); 2097673-FR (5473743-1); 2097673-FR (5473743-2); 2097673-FR (5473743-3); 2097673-FR (5473743-4); 2097673-FR (5473743-5); 2097673-FR (5473744-1); 2097673-FR (5473744-2); 2097673-FR (5473744-3); 2097673-FR (5473744-4); 2097673-FR (5473744-5); 2097673-FR (5473744-6); 2097673-FR (5458277-1); 2097673-FR (5458277-2); 2097673-001 (5455478-1); 2097673-IT (5476554-1); 2097673-IT (5476554-2); 2097673-IT (5476554-3); 2097673-NL (5450447-1); 2097673-NL (5450447-3); 2097673-NL (5450447-5); 2097673-NL (5450447-6); 2097673-NO (5474251-1); 2097673-001 (5476468-70); 2097673-001 (5476468-71); 2097673-001 (5476468-72); 2097673-001 (5476468-73); 2097673-001 (5476468-74); 2097673-001 (5476468-75); 2097673-001 (5476468-76); 2097673-001 (5476468-77); 2097673-001 (5476468-78); 2097673-001 (5476468-79); 2097673-001 (5476468-80); 2097673-001 (5476468-81); 2097673-001 (5476468-82); 2097673-001 (5476468-83); 2097673-001 (5476468-84); 2097673-001 (5476468-85); 2097673-001 (5476468-86); 2097673-001-US (4673852-1); 2097673-001-US (4673852-2); 2097673-001-US (4673852-3);   Additional Serial Numbers - Model Number, UDI Number, (Serial Number): 2097673-001-US, Not Applicable, (ANAM00306);  2097673-001-US, Not Applicable, (ANAP00354);  2097673-001-US, Not Applicable, (APWU00297);  2097673-001-US, Not Applicable, (ANAP00715);  2097673-001-US, Not Applicable, (ANAR00602);  2097673-001-US, Not Applicable, (ANAR00603);  2097673-001-US, Not Applicable, (ANAN00169);  2097673-001-US, Not Applicable, (ANAP00574);  2097673-001-US, Not Applicable, (ANAP00575);  2097673-001-US, Not Applicable, (ANAP00576);  2097673-001-US, Not Applicable, (ANAP00577);  2097673-001-US, Not Applicable, (ANAQ01175);  2097673-001-US, Not Applicable, (ANAP00172);  2097673-001-US, Not Applicable, (ANAP00861);  2097673-001-US, Not Applicable, (ANAP00870);  2097673-001-US, Not Applicable, (ANAP00872);  2097673-001-US, Not Applicable, (ANAS00398 );  2097673-001-US, Not Applicable, (ANAL00105);  2097673-001-US, Not Applicable, (ANAL00106);  2097673-001-US, Not Applicable, (ANAL00107);  2097673-001-US, Not Applicable, (ANAL00108);  2097673-001-US, Not Applicable, (ANAL00109);  2097673-001-US, Not Applicable, (ANAL00116);  2097673-001-US, Not Applicable, (ANAM00439);  2097673-001-US, Not Applicable, (ANAM00440);  2097673-001-US, Not Applicable, (ANAM00441);  2097673-001-US, Not Applicable, (ANAP01088);  2097673-001-US, Not Applicable, (ANAP01090);  2097673-001-US, Not Applicable, (ANAP01091);  2097673-001, Not Applicable, (ANAN00604);  2097673-001, Not Applicable, (ANAM01165);  2097673-001, Not Applicable, (ANAM01158);  2097673-001, Not Applicable, (ANAM00815);  2097673-001, Not Applicable, (ANAM00816);  2097673-001, Not Applicable, (ANAM00817);  2097673-001, Not Applicable, (ANAM00818);  2097673-001, Not Applicable, (ANAM00819);  2097673-001, Not Applicable, (ANAM00820);  2097673-001, Not Applicable, (ANAM00821);  2097673-001, Not Applicable, (ANAM00822);  2097673-001, Not Applicable, (ANAM00823);  2097673-001, Not Applicable, (ANAM00824);  2097673-DE, Not Applicable, (ANAP01156);  2097673-001, Not Applicable, (ANAR00318);  2097673-001, Not Applicable, (ANAR00319);  2097673-FR, Not Applicable, (ANAR05232);  2097673-FR, Not Applicable, (ANAR05233);  2097673-FR, Not Applicable, (ANAR05234);  2097673-FR, Not Applicable, (ANAR05235);  2097673-FR, Not Applicable, (ANAR05236);  2097673-FR, Not Applicable, (ANAP01419);  1011-9000-000, Not Applicable, (APWT00661);  1011-9000-000, Not Applicable, (APWT00662);  1011-9000-000, Not Applicable, (APWT00664);  1011-9000-000, Not Applicable, (ANAN00664);  1011-9000-000, Not Applicable, (ANAN00666);  1011-9000-000, Not Applicable, (ANAN00667);  1011-9000-000, Not Applicable, (ANAN00669);  1011-9000-000, Not Applicable, (ANAN00670);  1011-9000-000, Not Applicable, (ANAN00671);  1011-9000-000, Not Applicable, (ANAN00890);  1011-9000-000, Not Applicable, (ANAN00891);  1011-9000-000, Not Applicable, (ANAR00396);  1011-9000-000, Not Applicable, (APWT02012);  1011-9000-000, Not Applicable, (APWT02013);  1011-9000-000, Not Applicable, (ANAN01101);  1011-9000-000, Not Applicable, (ANAP00605);  2097673-FR, Not Applicable, (ANAQ00803);  2097673-FR, Not Applicable, (ANAQ00806);  2097673-FR, Not Applicable.(ANAQ00948);  2097673-FR, Not Applicable, (ANAR05145);  2097673-FR, Not Applicable, (ANAR05150);  2097673-FR, Not Applicable, (ANAR05513);  2097673-FR, Not Applicable, (ANAR05517);  2097673-FR, Not Applicable, (ANAS00665);  2097673-FR, Not Applicable, (ANAS00666);  2097673-FR, Not Applicable, (ANAS00668);  2097673-FR, Not Applicable, (ANAS00971);  2097673-NO, Not Applicable, (ANAQ01098);

510(k) numbers

["K110213","K170872"]

PMA numbers

not on file

Product code

BSZ

Firm FEI

2126677

Firm city

Waukesha

Firm state

WI

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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