Events

Recall of Device Recall MTAPSD2.4 TypeS Thermoplastic Mask

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Civco Medical Instruments 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
    46863
  • Event Risk Class
    Class 3
  • Event Number
    Z-1608-2008
  • Event Initiated Date
    2008-02-25
  • Event Date Posted
    2008-05-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-07-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=68348
  • 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
    Medical charged-particle radiation therapy system - Product Code IYE
  • Reason
    Mislabeled: the mask is mislabeled with the incorrect part number but the outer packaging is correct.
  • Action
    Consignees were notified by a Recall Notification letter on 2/25/08. The letter informed users that the recalling firm will replace the affected product. It also requested that users return a recall notification acknowledging notification of recall. Users were instructed to contact their sales representative to arrange servicing or for additional information at 1-800-842-8688.

Device

Device Recall MTAPSD2.4 TypeS Thermoplastic Mask
  • Model / Serial
    Lot Number: 34415.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution including USA states of IL, PA, NC, TN, SD, CA, MI, WI, MA, and CO; and country of Japan.
  • Product Description
    MT-APSD-2.4 Type-S Thermoplastic Mask, Medical charged-particle radiation therapy system; Disposable non-sterile (43.2cm) standard perforated thermoplastic head, neck and shoulder mask (2.4mm), 1 device per package; CIVCO Medical Solutions (MEDTEC), Orange City, IA 51041.
  • Manufacturer
    Civco Medical Instruments Inc

Manufacturer

Civco Medical Instruments Inc
  • Manufacturer Address
    Civco Medical Instruments Inc, 102 1st St S, Kalona IA 52247-9589
  • Manufacturer Parent Company (2017)
    Roper Technologies Inc
  • Source
    USFDA