FDA recall Z-2222-2021

Product

Electric MedSurg Bed FL23 - AC-powered adjustable hospital bed with four built-in electric DC motors and remote controls that is intended for medical purposes, Model Number: FL23, Part #FL23SE

Reason for recall

Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals

Distribution

Worldwide distribution - US Nationwide distribution and the countries of Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, Thailand.

Key facts

Status

Ongoing

Initiation date

2021-05-12

Report date

2021-08-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Portage, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2222-2021