FDA Medical Device Recalls (openFDA)
GE Healthcare: 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
- Recall number
- Z-1376-2015
- Recalling firm
- GE Healthcare
- 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
- Status
- Terminated
- Initiated
- 2015-02-27
- Posted
- 2015-04-02
- Terminated
- 2015-04-16
- Reason
- 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.
- Root cause
- 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
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K122445"]
- PMA numbers
- not on file
- Product code
- BSZ
- Firm FEI
- 2126677
- Firm city
- Waukesha
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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