Z-3183-2018Class II

PR1000 Pivot Rehab Bed AC powered adjustable bed

Name: Z-3183-2018 PR1000 Pivot Rehab Bed AC powered adjustable bed
Creator: Med-Mizer, Inc.
Published: 2018-07-25
License: https://open.fda.gov/license/

Med-Mizer, Inc. / initiated 2018-07-25 / Terminated / root cause: design

FDA source

Med-Mizer, Inc. began a recall of PR1000 Pivot Rehab Bed AC powered adjustable bed on 2018-07-25. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-3183-2018
Classification: Class II
Status: Terminated
Initiated: 2018-07-25
Posted: 2018-09-17
Terminated: 2019-10-11
Recalling firm: Med-Mizer, Inc.
Product: PR1000 Pivot Rehab Bed AC powered adjustable bed.
Product code: FNL Bed, Ac-Powered Adjustable Hospital
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
Root cause tag: design
FDA 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 in commerce: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3183-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3183-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-17

Product code FNL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)