Z-1376-2015Class II

GE Healthcare, Aespire 7900, Aespire View Anesthesia Machines. Model numbers 1009-9012-000. Intended to...

Name: Z-1376-2015 GE Healthcare, Aespire 7900, Aespire View Anesthesia Machines. Model numbers 1009-9012-000. Intended to...
Creator: GE Healthcare
Published: 2015-02-27
License: https://open.fda.gov/license/

GE Healthcare / initiated 2015-02-27 / Terminated / root cause: manufacturing process

FDA source

GE Healthcare began a recall of GE Healthcare, Aespire 7900, Aespire View Anesthesia Machines. Model numbers 1009-9012-000. Intended to provide general inhalation anesthesia and ventilatory... on 2015-02-27. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1376-2015
Classification: Class II
Status: Terminated
Initiated: 2015-02-27
Posted: 2015-04-02
Terminated: 2015-04-16
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
Product code: BSZ Gas-Machine, Anesthesia
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.
Root cause tag: manufacturing process
FDA 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 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1376-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1376-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-08	2015-04-02

Product code BSZ

K122445Class IIAespire 7900, Aespire ViewDatex-Ohmeda / cleared 2012-10-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)