Skip to content

Touchscreen display kit. Sold under the following product… recallZ-0413-2019 · GE Healthcare, LLC · initiated Sep 27, 2018

Class II Terminated All recalls posted in November 2018

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from GE Healthcare, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Software design

What the company is doing

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.

Recall details

Recall number
Z-0413-2019
Recall class
Class II
Status
Terminated
Initiated by the company
Sep 27, 2018
Posted by the FDA
Nov 9, 2018
Recalling firm
GE Healthcare, LLC
Quantity
4,207 units total
Product code
BSZ
FDA submissions
K110213, K170872
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.

Product description

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 (models, lots, serial numbers)

Show the full code information (8k characters)

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);

Other devices under the same FDA submission

2 devices cleared under K110213, K170872 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 81182).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page