PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: March 14, 2018 Initiated: July 14, 2017 #Z-0847-2018

Product Description

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.

Reason for Recall

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.

Details

Units Affected
2875 in total
Distribution
Worldwide Distribution - US Nationwide
Location
Mahwah, NJ

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Mindray DS USA, Inc. dba Mindray North America. Units affected: 2875 in total.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 14, 2018. Severity: Moderate. Recall number: Z-0847-2018.

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