A-Series A3/A5 Anesthesia Delivery System recall: Software Issue
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…
Why was A-Series A3/A5 Anesthesia Delivery System 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Units distributed or upgraded between March 2013 and December 21, 2016. Serial numbers requested.
- 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…
- Recalling firm
- Mindray DS USA, Inc. dba Mindray North America
- Quantity
- 2875 in total
- Distribution
- Worldwide Distribution - US Nationwide
- Recall date
- March 14, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)