Events

Recall of CHVH001A/1B Variable Helical Pitch (vHP) Software for TSX101A: Aquilion 64

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Toshiba American Medical Systems 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
    55542
  • Event Risk Class
    Class 2
  • Event Number
    Z-2204-2011
  • Event Initiated Date
    2010-04-09
  • Event Date Posted
    2011-05-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91086
  • 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
    System, x-ray, tomography, computed - Product Code JAK
  • Reason
    The recall was initiated by toshiba america medical systems (tams) because the software associated with tsx-101a: aquilion 64 can prevent scanning from being performed at the specified helical pitch (couch movement speed).
  • Action
    Toshiba America Medical Systems (TAMS) forwarded an Urgent: Medical Device Correction letter, dated 4/6/10, with attached Customer Reply Form, via US Postal Service to all customers who purchased the CHVH-001A/1B variable helical pitch (vHP) software for TSX-I0IA: Aquilion 64. The letter provides the customers with an explanation of the problem identified and actions to be taken. Customers were informed that a Toshiba service representative would contact them to schedule an appointment in order to install a corrective measure that will prevent the occurrence of the problem. Toshiba would like customers to set a scan range different from that for the previous scan for the second and subsequent vHP scans, if multiple vHP scans with the same scan conditions are performed in Auto Mode. Customers were instructed to complete and return the attached form and fax it to the toll free number at the top of the form. The form can also be sent via e-mail to raffairs@tams.com. Customers with any questions can contact the Director of Regulatory Affairs at (800) 421-1968 or contact their local Representative at (800) 521-1968.

Device

CHVH001A/1B Variable Helical Pitch (vHP) Software for TSX101A: Aquilion 64
  • Model / Serial
    SERIAL NUMBERS:  2089, 2114, 2302, 3204, 2037, 2014, 2040, 2898, 2054, 2042, 2067, 2202, 2241, 2100, 2038, 2101, 2102, 2244, 2097, 2931, 2900, 3085, 2412, 2595, 2106, 2041, 2108, 2113, 2130, 2135, 2147, 2158, 2063, 2157, 2161, and  2243.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- MN, OH, MO, MI, NY, KS, MD, TX, NJ, IL, ID, TN, AZ, PA, HI, GA, MT, WA, FL, NC, WI, ME, & CA.
  • Product Description
    CHVH-001A/1B Variable Helical Pitch (vHP) Software for TSX-101A: Aquilion 64; System, X-Ray, Tomography Computed
  • Manufacturer
    Toshiba American Medical Systems Inc

Manufacturer

Toshiba American Medical Systems Inc
  • Manufacturer Address
    Toshiba American Medical Systems Inc, 2441 Michelle Dr, P.O. Box 2068, Tustin CA 92781-2068
  • Manufacturer Parent Company (2017)
    Canon Inc
  • Source
    USFDA