Z-0584-2019Class II

PROCARE B40 Patient Monitor, V1; and B40 Patient Monitor, V2, V2.1, and V3. The PROCARE Monitor B40 is a...

Name: Z-0584-2019 PROCARE B40 Patient Monitor, V1; and B40 Patient Monitor, V2, V2.1, and V3. The PROCARE Monitor B40 is a...
Creator: GE Healthcare, LLC
Published: 2018-09-11
License: https://open.fda.gov/license/

GE Healthcare / initiated 2018-09-11 / Open, Classified / root cause: software

FDA source

GE Healthcare, LLC began a recall of PROCARE B40 Patient Monitor, V1; and B40 Patient Monitor, V2, V2.1, and V3. The PROCARE Monitor B40 is a portable multiparameter unit to be used for monitoring... on 2018-09-11. FDA classified it as Class II and gives the reason as "Patient monitors may restart due to network overload caused by network configuration". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0584-2019
Classification: Class II
Status: Open, Classified
Initiated: 2018-09-11
Posted: 2018-12-07
Recalling firm: GE Healthcare
Product: PROCARE B40 Patient Monitor, V1; and B40 Patient Monitor, V2, V2.1, and V3. The PROCARE Monitor B40 is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport.
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Reason for recall: Patient monitors may restart due to network overload caused by network configuration.
Root cause tag: software
FDA root cause: Software design
Action: The recalling firm, GE Healthcare, issued "URGENT MEDICAL DEVICE CORRECTION" letters dated 9/11/2018 via trackable mail on 9/11/2018 to its customers. The letters described the product, problem and actions to be taken. The letters informed the customer of the issue and providing safety instructions for mitigation of the issue if a prolonged network overload occurs and the Bx0 and/or B1x5 patient monitor on the network does not resume normal functionality in approximately 90 seconds. The customers were instructed to follow the safety instructions. GE Healthcare will provide revised network installation and user instructions documentation at no cost to you in a future mailing. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Quantity in commerce: 33,065 patient monitors
Distribution: Worldwide Distribution: US (nationwide) including Puerto Rico; and countries of: Algeria, Argentina, Australia, Austria, Azerbaijan, Bahamas, Bangladesh, Belgium, Bolivia, Bosnia-Herzegovina, Brazil, Brunei, Bulgaria, Burma (Myanmar), Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Ethiopia, Finland, France, Gabon, Georgia, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Ivory Coast, Jamaica, Jordan, Kampuchea, Kazakstan, Kenya, Korea, Kuwait, Lebanon, Lithuania, Macedonia, Malaysia, Mexico, Moldova, Morocco, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Senegal, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Viet Nam, and Zambia.
Product codes and lots: All monitors

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0584-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0583-2019	Class II	Ongoing	Voluntary: Firm initiated	2018-12-19	2018-12-07
Z-0584-2019	Class II	Ongoing	Voluntary: Firm initiated	2018-12-19	2018-12-07
Z-0585-2019	Class II	Ongoing	Voluntary: Firm initiated	2018-12-19	2018-12-07
Z-0586-2019	Class II	Ongoing	Voluntary: Firm initiated	2018-12-19	2018-12-07
Z-0587-2019	Class II	Ongoing	Voluntary: Firm initiated	2018-12-19	2018-12-07

Product code MHX

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)