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U.S. Department of Health and Human Services

Class 2 Device Recall Aespire 7900, Aespire View

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  Class 2 Device Recall Aespire 7900, Aespire View see related information
Date Initiated by Firm February 27, 2015
Date Posted April 02, 2015
Recall Status1 Terminated 3 on April 16, 2015
Recall Number Z-1376-2015
Recall Event ID 70677
510(K)Number K122445  
Product Classification Gas-machine, anesthesia - Product Code BSZ
Product GE Healthcare, Aespire 7900, Aespire View Anesthesia Machines. Model numbers 1009-9012-000.

Intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients
Code Information Mfg Lot or Serial # ANCU00179 ANCU00114 ANCU00115 ANCU00116 ANCU00117 ANCU00118 ANCU00119 ANCU00120 ANCU00121 ANCU00178 ANCU00105 ANCU00123 ANCU00124 ANCU00125 ANCU00129 ANCU00130 ANCU00126 ANCU00108 ANCU00113 ANCU00112 ANCU00193 ANCU00174 ANCU00137 ANCU00175 ANCU00134 ANCU00135 ANCU00136 ANCU00150 ANCU00151 ANCU00138 ANCU00152 ANCU00140 ANCU00172 ANCU00139 ANCU00153 ANCU00141 ANCU00142 ANCU00143 ANCU00149 ANCU00147 ANCU00148 ANCU00146 ANCU00145 ANCU00101 ANCU00102 ANCU00103 
Recalling Firm/
Manufacturer		 GE Healthcare
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact GE Healthcare Service
800-437-1171
Manufacturer Reason
for Recall		 Specific Aespire 7900 Anesthesia Machines have an increased likelihood of failure of the CPU circuit board. This could result in a blank display or loss of mechanical ventilation.
FDA Determined
Cause 2		 Process control
Action Consignees were sent a GE Healthcare "Urgent Medical Device Correction" letter GEHC Ref# 34064, dated February 27, 2015. The letter was addressed to Chief of Anesthesia, Health Care Administrator / Risk Manager and Director of Biomedical / Clinical Engineering. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. The letter stated that customers can continue to use the affected device in Manual Ventilation mode, and contact their local GE Healthcare Service Representative. GE Healthcare will correct all affected devices at no cost to the customers. A Service Representative will contact customers to arrange for the correction. For questions or concerns contact GE Healthcare Service at 1-800-437-1171, or your local Service Representative.
Quantity in Commerce 46 (10 units US, 36 units OUS)
Distribution Worldwide Distribution -- US, including the states of NC and OK; and the countries of CHINA, INDIA, JAPAN, MEXICO, and VENEZUELA.
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
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