Mindray A-Series Anesthesia Delivery System Software Recall
Mindray is recalling 2,875 A-Series anesthesia delivery systems due to a software issue that may apply incorrect settings or skip startup leak tests.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device (anesthesia system) where a software defect could lead to incorrect settings or skipped safety tests, representing a risk of harm even though no specific injuries are reported in the source text.
Plain-English summary
Mindray DS USA, Inc. dba Mindray North America is recalling 2,875 units of the A-Series A3/A5 Anesthesia Delivery System. The affected model numbers are 0633F-01000-0X (A3) and 0631F-01000-0X (A5). These devices are used in health care facilities to administer general inhalation anesthetics and maintain patient ventilation for adult, pediatric, and infant populations.
The recall is due to a software issue that may result in previous settings being applied instead of the default settings, or the unit may skip the startup leak test. The affected units were distributed or upgraded between March 2013 and December 21, 2016, and were distributed worldwide and nationwide in the US.
Health care facilities should contact Mindray for instructions on how to resolve the software issue. The source text does not specify the number of reported injuries or illnesses associated with this recall.
The recalled product
- Product
- A-Series A3/A5 Anesthesia Delivery System; Model Numbers: 0633F-01000-0X (A3) and 0631F-01000-0X (A5) 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
- Manufacturer
- Mindray DS USA, Inc. dba Mindray North America
- Affected units
- 2,875
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Units distributed or upgraded between March 2013 and December 21
- 2016. Serial numbers requested.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Mindray DS USA, Inc. dba Mindray North America under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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