Reported Mar 14, 2018 · Terminated
A-Series A3/A5 Anesthesia Delivery System; Model Numbers: 0633F-01000-0X (A3) and 0631F-01000-0X (A5) Product Usage:…
Mindray DS USA, Inc. dba Mindray North America
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Mindray DS USA, Inc. dba Mindray North America · 800 Macarthur Blvd · Mahwah, NJ · 07430-2001
Is this the product you have?
- A-Series A3/A5 Anesthesia Delivery System
- Model Numbers0633F-01000-0X (A3)
- and 0631F-01000-0X (A5) Product UsageThe 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
- Lot codes and dates
- Units distributed or upgraded between March 2013 and December 21, 2016. Serial numbers requested.
- Amount recalled
- 2875 in total
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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