Events

Recall of Device Recall DCI Equipment; Marus MaxStar; Marus NuStar; Pelton & Crane Spirit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Dental Equipment LLC.

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
    58122
  • Event Risk Class
    Class 2
  • Event Number
    Z-1958-2011
  • Event Initiated Date
    2011-03-01
  • Event Date Posted
    2011-04-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-09-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98425
  • 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
    dental chair - Product Code NRU
  • Reason
    Link arm assembly that mounts the rear mounted accessories to the dental chair may potentially break and fall off the dental chair.
  • Action
    On 03/08/11, Dental Equipment LLC. started sending out the Medical Device Recall notification letter via USPS 1st class mail to US consignees and Federal Express mail to foreign consignees. The firm also sent a recall notification letter to consignees who only purchased dental accessories such as Rear Mounted Cuspidor with Coverset, Arm Articulating Rear Mounted Cuspidor - Marus Gray, Maxstar Orbit Cuspidor utility W/ Porcelain bowl, and zinc plated bolts. The letter identified the affected dental chair as Marus brand with the following model numbers: DC1490, DC1690, DC1700 and DC1702. The firm's corrective action including the replacement of the affected link arm assembly with a new link arm assembly. The firm's field representative will contact each consignee for an appointment to replace the affected link arm assembly. Consignees can contact the Dental Equipment LLC at 503-537-3617 for any questions.

Device

Device Recall DCI Equipment; Marus MaxStar; Marus NuStar; Pelton & Crane Spirit
  • Model / Serial
    Part number for the bolt: 022R065  Chair Serial Numbers: 1961, 2127, 2260, 239446, 239446, 240619, 241535, 242384, 242711, 242862, 244489, 244502, 244530, 244977, 245874, 246275, 246526, 247557, 247813, 247976, 248040, 248871, 249015, 249235, 249238, 249441, 249784, 218756C, 2250, 2251, 240126, 240126A , 240605, 240605A, 240605B, 240605C, 240605D, 240605E, 241379, 241379A, 241379B, 242154J, 242154K, 242154L, 245767, 245767F, 246769, 246769A , 247199AE, 247199AJ, 248129F, 248321, 248321A, 248378C, 248824, and 248824A.
  • Product Classification
    Dental Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution to USA, Australia, Canada, Ireland, South Africa, and Vietnam.
  • Product Description
    Dental chairs distributed under several brand names such as DCI Equipment; Marus MaxStar; Marus NuStar; and Pelton & Crane. || Part number for the bolt: 022R065 || Product is labeled in part: || DCI Equipment, Mfg By: Dental Equipment, LLC. DC1235, || Marus Dental, Mfg By: Dental Equipment, LLC. DC1490, DC1690, and DC1700, and DC1702, || Pelton & Crane, Spirit SP17.
  • Manufacturer
    Dental Equipment LLC

Manufacturer

Dental Equipment LLC
  • Manufacturer Address
    Dental Equipment LLC, 705 S Springbrook Rd Bldg B200, Newberg OR 97132-7057
  • Source
    USFDA