—#167402

Product

PROCARE B20 Patient Monitor, V1; and B20 Patient Monitor, V2. The PROCARE Monitor B20 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 intrahospital transport.

FDA product code: MHX — Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K122253
Affected lot / code info: All monitors

Why it was recalled

Patient monitors may restart due to network overload caused by network configuration.

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: GE Healthcare, LLC
Address: 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2018-09-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #167402. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.