B105/125 Patient Monitor. The device is a portable recall
B105/125 Patient Monitor. The device is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for…
Why was B105/125 Patient Monitor. The device is a portable recalled?
Patient monitors may restart due to network overload caused by network configuration.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All monitors
- Product
- B105/125 Patient Monitor. The device is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for…
- Recalling firm
- GE Healthcare, LLC
- Quantity
- 5,516 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.
- Recall date
- December 19, 2018
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)