Events

Recall of Device Recall Midland SpaceSaver Mat Platform

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by SAMMONS PRESTON ROLYAN.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    34510
  • Event Risk Class
    Class 2
  • Event Number
    Z-1211-06
  • Event Initiated Date
    2006-01-25
  • Event Date Posted
    2006-07-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-04-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43981
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Wood tables Plinth - Product Code INT
  • Reason
    There have been reports of structural failure on the skirt of select tables. the risk to patients presented by possible structural failure of the skirt of the table is a slow collapse of the plinth which could cause the patient to be displaced.
  • Action
    Letters were sent to customers certified mail on 1/25-26/2006 instructing them to take the tables out of service until it could be inspected by a sales representative. Sales represenatives are following up with customers in person to inspect tables.

Device

Device Recall Midland SpaceSaver Mat Platform
  • Model / Serial
    Serial number prefixess 2509 throuth 2511
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide including the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV.
  • Product Description
    ValueLine Space-Saver Folding Mat Platform model C9222-30S; C2230S
  • Manufacturer
    SAMMONS PRESTON ROLYAN

Manufacturer

SAMMONS PRESTON ROLYAN
  • Manufacturer Address
    SAMMONS PRESTON ROLYAN, W.68 N.158 Evergreen Blvd., Cedarburg WI 53012
  • Source
    USFDA