GE Healthcare, LLC: Medical Device Recall in 2018 - (Recall #: Z-0413-2019)

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.

Class II

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.

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);

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.

Voluntary: Firm initiated