Recall Z-1376-2015— GE Healthcare
Class II · Terminated
Class II FDA medical device recall by GE Healthcare, initiated 2015-02-27, terminated 2015-04-16. It names one FDA 510(k) clearance: K122445. 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. 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..
- Recalling firm
- GE Healthcare
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-02-27
- Terminated
- 2015-04-16
- Firm location
- Waukesha, WI, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.