FDAFDA · Food and drugs·Recall number Z-0847-2018
A-Series A7 Anesthesia Delivery System; Model Number: 0632F-PA0000X (A7) Product Usage: The A-Series Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic, and to maintain a patient s ventilation. The A-Series is intended for use by licensed clinicians, for patients requiring anesthesia within a health care facility, and can be used for adult, pediatric, and infant populations.
Published March 14, 2018 · Recall initiated: July 14, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
A software issue may result in the previous settings being applied instead of the default settings or the unit may skip the startup leak test.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Mindray DS USA, Inc. dba Mindray North America
- Distributor
- Worldwide Distribution - US Nationwide
- Lot
- Units distributed or upgraded between March 2013 and December 21, 2016. Serial numbers requested.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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