CLASS II Device recall · Reported 14 Mar 2018 · FDA Enforcement Report
A-Series A3/A5 Anesthesia Delivery System recalled by Mindray DS USA
Mindray DS USA is recalling A-Series A3/A5 Anesthesia Delivery System, distributed nationwide in the US. The recall was initiated on 14 Jul 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0846-2018
- FDA event ID
- 79133
- Recalling firm
- Mindray DS USA, Mahwah, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Jul 2017
- FDA classified
- 2 Mar 2018
- Reported
- 14 Mar 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 14 Jul 2017 | Recall initiated by company | |
| 2 Mar 2018 | Classified by FDA | +231 days |
| 14 Mar 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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 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.
Where it was distributed
Worldwide Distribution - US Nationwide
Questions about this recall
Is A-Series A3/A5 Anesthesia Delivery System recalled?
Yes. Mindray DS USA recalled A-Series A3/A5 Anesthesia Delivery System on 14 Jul 2017. The recall is Class II and its status is Terminated. Recall number Z-0846-2018.
Why was it 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.
Which lots are affected?
Units distributed or upgraded between March 2013 and December 21, 2016. Serial numbers requested.
Where was it sold?
Worldwide Distribution - US Nationwide
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Mindray DS USA
All 39| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Hardware configuration of the BeneVision Central Monitoring recalled | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS II | The Anesthesia System is a device used to administer to recalled | Mindray DS USA | Packaging Defects | Nationwide |
| Device | CLASS II | The Anesthesia System is a device used to administer to recalled | Mindray DS USA | Packaging Defects | Nationwide |
| Device | CLASS II | BeneVision N1 Patient Monitor (N1) recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
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