FDA recall Z-3183-2018

Med-Mizer, Inc. · Class II · device

Product

PR1000 Pivot Rehab Bed AC powered adjustable bed.

Reason for recall

Under certain conditions, when pivoting bed to the extreme left there are situations where the wire/cables may become pinched. A failure would result in the resident requiring to be transferred to a different bed until repairs can be made

Distribution

The products were distributed to the following US states: AR, AZ, FL, GA, IA, ID, IL, IN, KY, ME, MI, MN, MO, NC, ND, NE, NM, NY, OH, OK, PA, SC, SD, TN, TX, VA, WA, and WI. The products were distributed to the following foreign countries: Canada, China, and Denmark.

Key facts

Status
Terminated
Initiation date
2018-07-25
Report date
2018-09-26
Termination date
2019-10-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
Batesville, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3183-2018