Events

Recall of XPRT Therapy Mattress Systems

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Gaymar Industries Inc.

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
    30065
  • Event Risk Class
    Class 2
  • Event Number
    Z-0260-05
  • Event Initiated Date
    2004-10-25
  • Event Date Posted
    2004-11-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-02-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35105
  • 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
    Bed, Patient Rotation, Powered - Product Code IKZ
  • Reason
    Design control/validation deficiencies.
  • Action
    Letter dated 10/25/2004 to Stryker Medical, own-label distributor, with instructions to remove patients from the system and return units to Gaymar.

Device

XPRT Therapy Mattress Systems
  • Model / Serial
    The following serial numbers, which represent all units shipped: H40001 thru H40038; and I40001, I40003, I40004, I40005, I40006, I40009, I40012, I40013, I40014, I40017, I40018, and I40021.
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The units were sold to the own-label distributor, who in turn sold 8 units to two hospitals in Nebraska and Hawaii.
  • Product Description
    XPRT Therapy Mattress Systems: || Model # 2950-000-000 with Dartex urethane-coated nylon cover (deluxe cover); and Model # 2950-000-001 with nylon cover without coating (standard cover). || Responsible firm on the label: Manufactured for STRYKER MEDICAL, 6300 South Sprinkle Road, Kalamazoo, MI USA 49001-9799, 1-800-327-0770. || The unit consists of a sleep surface, an integrated valve box located in the head of the mattress, a pump box located under the foot of the mattress and a color touch screen controller that can be mounted to either side of the pump box at the foot end of the mattress.
  • Manufacturer
    Gaymar Industries Inc

Manufacturer

Gaymar Industries Inc
  • Manufacturer Address
    Gaymar Industries Inc, 10 Centre Dr, Orchard Park NY 14127-2280
  • Source
    USFDA