Z-0237-2020Class II

Rosie4 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing software version...

Name: Z-0237-2020 Rosie4 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing software version...
Creator: Mindray DS USA, Inc. dba Mindray North America
Published: 2019-10-01
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2019-10-01 / Terminated

FDA source

Mindray DS USA, Inc. dba Mindray North America began a recall of Rosie4 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing software version 8.1.5 - Product Usage: The monitor is intended for... on 2019-10-01. FDA classified it as Class II and gives the reason as "NIBP valve assembly board subject to this recall includes enhancements that are not included in the current marketing clearance:1. Anti-motion feature 2. NIBP hose blockage identification function". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0237-2020
Classification: Class II
Status: Terminated
Initiated: 2019-10-01
Posted: 2019-10-29
Terminated: 2021-08-06
Recalling firm: Datascope Corp.
Product: Rosie4 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing software version 8.1.5 - Product Usage: The monitor is intended for monitoring physiologic parameters, including Pulse Oximetry (SpO2), Pulse Rate (PR), Non Invasive Blood Pressure (NIBP). Temperature (TEMP) and Carbon Dioxide (CO2) on adult, pediatric, and neonatal patients in professional healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians
Product code: MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Reason for recall: NIBP valve assembly board subject to this recall includes enhancements that are not included in the current marketing clearance:1. Anti-motion feature 2. NIBP hose blockage identification function
FDA root cause: No Marketing Application
Action: Mindray communicated by letter on 10/1/19 to consignees and distributors by certified postal mail with return receipt verification: to consignees that have affected vital sign monitor; communication to consignees that purchased directly NIBP valve assembly boards; communication to distributors that have affected vital sign monitor. Consignees were instructed to contact Mindrays Repair Center to arrange for affected units to be returned for a software update.
Quantity in commerce: 14 units
Distribution: US Nationwide distributions.
Product codes and lots: NIBP valve assembly board, p/n 115-017679-00, containing software version 8.1.5

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0237-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0235-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-06	2019-10-29
Z-0236-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-06	2019-10-29
Z-0237-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-06	2019-10-29
Z-0238-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-06	2019-10-29

Product code MWI

K170712Class IIAccutorr 7/VS-900 Vital Signs MonitorShenzhen Mindray Bio-Meidcal Electronics Co., Ltd. / cleared 2017-08-02

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)