FDA-Device2018-09-26Class II

PR1000 Pivot Rehab Bed AC powered adjustable bed.

Med-Mizer, Inc.
Hazard

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

Sold states
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.
Affected count
230 units
Manufactured in
80 Commerce Dr, N/A, Batesville, IN, United States
Products
PR1000 Pivot Rehab Bed AC powered adjustable bed.

Official notice

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

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