CLASS II Device recall · Reported 8 Apr 2015 · FDA Enforcement Report

Aespire 7900, Aespire View Anesthesia Machines recalled by GE Healthcare

GE Healthcare is recalling Aespire 7900, Aespire View Anesthesia Machines, distributed in North Carolina, Oklahoma. The recall was initiated on 27 Feb 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesMfg 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

Quantity recalled46 (10 units US, 36 units OUS)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1376-2015
FDA event ID: 70677
Recalling firm: GE Healthcare, Waukesha, WI
Classification: Class II
Status: Terminated
Recall initiated: 27 Feb 2015
FDA classified: 2 Apr 2015
Reported: 8 Apr 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: CPAP & Ventilators

Timeline

27 Feb 2015	Recall initiated by company
2 Apr 2015	Classified by FDA	+34 days
8 Apr 2015	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

Worldwide Distribution -- US, including the states of NC and OK; and the countries of CHINA, INDIA, JAPAN, MEXICO, and VENEZUELA.

North Carolina Oklahoma

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

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

Where was it sold?

Worldwide Distribution -- US, including the states of NC and OK; and the countries of CHINA, INDIA, JAPAN, MEXICO, and VENEZUELA.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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