FDA Medical Device Recalls (openFDA)
Med-Mizer, Inc.: PR1000 Pivot Rehab Bed AC powered adjustable bed.
- Recall number
- Z-3183-2018
- Recalling firm
- Med-Mizer, Inc.
- Product
- PR1000 Pivot Rehab Bed AC powered adjustable bed.
- Status
- Terminated
- Initiated
- 2018-07-25
- Posted
- not on file
- Terminated
- 2019-10-11
- 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
- Root cause
- Device Design
- 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.
- Quantity
- 230 units
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FNL
- Firm FEI
- 3004976058
- Firm city
- Batesville
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28