Mindray A7 Anesthesia Delivery System Recalled for Software Defect
Mindray is recalling A7 Anesthesia Delivery Systems because a software issue may cause incorrect settings to be applied or the startup leak test to be skipped.
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 is classified as FDA Class II and involves a medical device used for anesthesia where a software defect could lead to incorrect settings or skipped safety tests, representing a risk of harm even though no injuries are reported in the source text.
Plain-English summary
Mindray DS USA, Inc. dba Mindray North America is recalling the A-Series A7 Anesthesia Delivery System (Model Number: 0632F-PA0000X). The recall involves 2,875 units that were distributed or upgraded between March 2013 and December 21, 2016. 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 source text does not report any specific injuries or illnesses associated with this defect.
Health care facilities should contact Mindray DS USA, Inc. dba Mindray North America for instructions on how to resolve the software issue. The recall is classified as Class II by the FDA.
The recalled product
- 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
- 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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