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Recall Observatory FDA recall evidence

Device product

PR1000 Pivot Rehab Bed AC powered adjustable bed.

Z-3183-2018

July 25, 2018

Class II

Product summary

Firm
Med-Mizer, Inc.
Event
Event 80832
Status
Terminated
Classification
Class II
Quantity
230 units
Official record key
device-enforcement:Z-3183-2018

Official wording

Reason: 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

Code information: ALL Pivot Rehab PR1000 Beds built between 12/01/2010 thru 12/22/2014 SN: PR 10001 build date 12/01/2010 thru PR 10255 build date 12/22/2014

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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