FDA Medical Device Recalls (openFDA)
Mindray DS USA, Inc. dba Mindray North America: 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.
- Recall number
- Z-0847-2018
- Recalling firm
- Mindray DS USA, Inc. dba Mindray North America
- Product
- 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.
- Status
- Terminated
- Initiated
- 2017-07-14
- Posted
- not on file
- Terminated
- 2019-04-17
- Reason
- 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.
- Root cause
- Device Design
- Action
- Mindray sent an Urgent Medical Device Correction letter dated June 9, 2017 to affected customers. The letter identified the affected product, problem and actions to be taken. Corrective Action: In order to eliminate any potential for the EEPROM issue to manifest, Mindray is offering two options for upgrading affected systems in your facility: Option 1: You may perform the software upgrade if your facility has Biomedical Engineering or other staff that have been trained by Mindray to perform maintenance operations on the ASeries. Please contact Mindray's Technical Support team who will assist with providing the software and instructions for performing the software upgrade. The Technical Support can be reached at (877) 913-9663 (Option 1). Option 2: A Mindray Service Representative will upgrade the affected systems in your facility at no charge. Please contact your Mindray Service Representative to arrange for this upgrade at (877) 913-9663 (Option 8). Both the Technical Support and Service teams may be reached Monday through Friday, 8:30am - 5:30pm, ET.
- Quantity
- 2875 in total
- Distribution
- Worldwide Distribution - US Nationwide
- Lot, serial or model codes
- Units distributed or upgraded between March 2013 and December 21, 2016. Serial numbers requested.
- 510(k) numbers
- ["K151954"]
- PMA numbers
- not on file
- Product code
- BSZ
- Firm FEI
- 2221819
- Firm city
- Mahwah
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28