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U.S. Department of Health and Human Services

Class 2 Device Recall Aisys Anesthesia System

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  Class 2 Device Recall Aisys Anesthesia System see related information
Date Initiated by Firm September 27, 2018
Date Posted November 09, 2018
Recall Status1 Terminated 3 on April 12, 2021
Recall Number Z-0413-2019
Recall Event ID 81182
510(K)Number K110213  K170872  
Product Classification Gas-machine, anesthesia - Product Code BSZ
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.
Code Information 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);  
Recalling Firm/
Manufacturer		 GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
800-437-1171
Manufacturer 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.
FDA Determined
Cause 2		 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 in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = BSZ and Original Applicant = DATEX-OHMEDA, INC.
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