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Terminated

PR1000 Pivot Rehab Bed AC powered adjustable bed.

FDA Recall Z-3183-2018 · Posted None

Recalling FirmMed-Mizer, Inc.
Recall StatusTerminated
Product CodeFNL
Date Initiated2018-07-25
Date Terminated2019-10-11
Product Quantity230 units

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

Firm Action

Customers were contacted via telephone on 7/25/18 to notify them of the issue and to make them aware of the correction. Customers were then mailed a notification letter along with necessary parts.

Root Cause

Device Design

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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