Z-0847-2018Class II

A-Series A7 Anesthesia Delivery System; Model Number: 0632F-PA0000X (A7)

Name: Z-0847-2018 A-Series A7 Anesthesia Delivery System; Model Number: 0632F-PA0000X (A7)
Creator: Mindray DS USA, Inc. dba Mindray North America
Published: 2017-07-14
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2017-07-14 / Terminated / root cause: design

FDA source

Mindray DS USA, Inc. dba Mindray North America began a recall of 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... on 2017-07-14. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0847-2018
Classification: Class II
Status: Terminated
Initiated: 2017-07-14
Posted: 2018-03-02
Terminated: 2019-04-17
Recalling firm: Datascope Corp.
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 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.
Product code: BSZ Gas-Machine, Anesthesia
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.
Root cause tag: design
FDA root cause: Device Design
Action: Mindray sent an Urgent Medical Device Correction letter dated June 9, 2017 to affected customers. The letter identified the affected product, problem and actions to be taken. Corrective Action: In order to eliminate any potential for the EEPROM issue to manifest, Mindray is offering two options for upgrading affected systems in your facility: Option 1: You may perform the software upgrade if your facility has Biomedical Engineering or other staff that have been trained by Mindray to perform maintenance operations on the ASeries. Please contact Mindray's Technical Support team who will assist with providing the software and instructions for performing the software upgrade. The Technical Support can be reached at (877) 913-9663 (Option 1). Option 2: A Mindray Service Representative will upgrade the affected systems in your facility at no charge. Please contact your Mindray Service Representative to arrange for this upgrade at (877) 913-9663 (Option 8). Both the Technical Support and Service teams may be reached Monday through Friday, 8:30am - 5:30pm, ET.
Quantity in commerce: 2875 in total
Distribution: Worldwide Distribution - US Nationwide
Product codes and lots: Units distributed or upgraded between March 2013 and December 21, 2016. Serial numbers requested.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0847-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0846-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-14	2018-03-02
Z-0847-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-14	2018-03-02

Product code BSZ

K151954Class IIA7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. / cleared 2015-10-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)