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

Lot, batch or date codesUnits distributed or upgraded between March 2013 and December 21, 2016. Serial numbers requested.

Quantity recalled2875 in total

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: E-Mail
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

Nationwide

Questions about this recall

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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 79133

This product is part of a recall event; the main page for the event is A-Series A7 Anesthesia Delivery System recalled by Mindray DS USA.

Reported	Class	Recall	Company	Reason	Where
14 Mar 2018	CLASS II	A-Series A7 Anesthesia Delivery System recalled by Mindray DS USA	Mindray DS USA	Packaging Defects	Nationwide

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