Agency classClass IIOur severity:High FDA (Devices)·Z-0847-2018·Announced 2018-03-14

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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
Category: Medical Device — Anesthesia Delivery System
Hazard: software-defect
incorrect-settings
skipped-safety-test
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.

See all 2 products in this recall →

Same manufacturer · Mindray DS USA, Inc. dba Mindray North America

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Same hazard · software defect