CLASS II ONGOING Device recall · Reported 19 Dec 2018 · FDA Enforcement Report

B105/125 Patient Monitor recalled by GE Healthcare

GE Healthcare is recalling B105/125 Patient Monitor, distributed nationwide in the US. The recall was initiated on 11 Sep 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll monitors

Quantity recalled5,516 patient monitors

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0587-2019
FDA event ID: 81077
Recalling firm: GE Healthcare, Waukesha, WI
Classification: Class II
Status: Ongoing
Recall initiated: 11 Sep 2018
FDA classified: 7 Dec 2018
Reported: 19 Dec 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Patient Monitors

Timeline

11 Sep 2018	Recall initiated by company
7 Dec 2018	Classified by FDA	+87 days
19 Dec 2018	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

B105/125 Patient Monitor. The device 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.

Where it was distributed

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.

Nationwide Georgia Puerto Rico

Questions about this recall

Why was it recalled?

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

Which lots are affected?

All monitors

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

4 other products · FDA event 81077

This product is part of a recall event; the main page for the event is Procare B20 Patient Monitor, V1 recalled by GE Healthcare.

Reported	Class	Recall	Company	Reason	Where
19 Dec 2018	CLASS II	Procare B20 Patient Monitor, V1 recalled by GE Healthcare	GE Healthcare	Device Malfunction	Nationwide
19 Dec 2018	CLASS II	B20i Patient Monitor and B20i V2 Patient Monitor recalled	GE Healthcare	Device Malfunction	Nationwide
19 Dec 2018	CLASS II	B40i Patient Monitor and B40i Patient Monitor V3 The device recalled	GE Healthcare	Device Malfunction	Nationwide
19 Dec 2018	CLASS II	Procare B40 Patient Monitor, V1 recalled by GE Healthcare	GE Healthcare	Device Malfunction	Nationwide

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