GE Healthcare, LLC recalls Solar 8000M Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal pa…

Recall date

August 31, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0523-2019

FDA classification

Class II

Brand / firm

GE Healthcare, LLC

Sold / distributed

Distribution was made nationwide, including Puerto Rico, Guam, and Samoa. There was also government and military distribution. Foreign distribution was made to Canada, Algeria, Angola, Argentina, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bermuda, Bolivia, Bosni…

Why it was recalled

The patient monitors may simultaneously restart as designed if all are connected to the same network and a network overload occurs for a prolonged time.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Solar 8000M Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.