Events

Recall of Device Recall Carestream Touch Prime and Carestream Touch Prime XE

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Carestream Health 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
    76213
  • Event Risk Class
    Class 2
  • Event Number
    Z-1052-2017
  • Event Initiated Date
    2016-11-21
  • Event Date Posted
    2017-01-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152532
  • 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, imaging, pulsed doppler, ultrasonic - Product Code IYN
  • Reason
    Software error; carestream health inc, received a complaint stating that when a user accidentally obtains a measurement value of 0 and corrects the value in the report, the resulting measurement unit is not displayed, i.E., centimeters or millimeters. as such, the user expects that the measurement is taken calculated in centimeters, consistent with other values in the report. in actuality, the measurement is taken in millimeters. when this updated measurement is used in an average calculation, the result appears incorrect as two measurements are interpreted as centimeters while the user corrected value is interpreted as millimeters. if the user selects a calc result display as min or max, the values are also interpreted as millimeters when centimeters were expected.
  • Action
    Carestream sent an URGENT: MEDICAL DEVICE CORRECTION Letter dated November 17, 2016, with a Consignee Notification Acknowledgement (HRA # MA-2016-019) to all affected US consignees via UPS on November 21, 2016. The letter identified the product, the problem, and the action to be taken by the consignee Action to be Taken: When reviewing the worksheet, if a zero value is observed and that calculation field needs to be changed, the calculation needs to be deleted from the worksheet. Once deleted, the user needs to acquire a new calculation from a clinical image. Carestream is currently validating a fix for this problem and your local service representative will be contacting you within the next few weeks to arrange to upgrade your software. If you have any questions or concerns, please contact the Carestream Customer Care Center in the U.S. at 1-800-328-2910, available 7 days per week on a 24 hour basis. Outside of the U.S., please call your local Service support number. If you have distributed the device outside your facility, please alert your customer(s) of this field correction and contact Carestream Customer Care Center as listed above..

Device

Device Recall Carestream Touch Prime and Carestream Touch Prime XE
  • Model / Serial
    Serial Numbers: US units: 106, 112, 114, 116, 1021, 1037, 1038, 1044, 1057, 1067, 1072, 1074, 1079, 1090; OUS units: 1005, 1006, 1009, 1011, 1015, 1017, 1018, 1020, 1031, 1041, 1042, 1043, 1045, 1081, 1086, 1089.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US including SC, GA, TX, OH, IA, NY and foreign distribution to Switzerland and Malaysia
  • Product Description
    Carestream Touch Prime, Catalog # 1738830, and Touch Prime XE, Catalog # 1738822, Ultrasound System || Diagnostic ultrasound imaging or fluid flow analysis of the human body
  • Manufacturer
    Carestream Health Inc

Manufacturer

Carestream Health Inc
  • Manufacturer Address
    Carestream Health Inc, 150 Verona St, Rochester NY 14608-1733
  • Manufacturer Parent Company (2017)
    ONEX Corp
  • Source
    USFDA