Class 2 Device Recall Carestream Touch Prime and Carestream Touch Prime XE

• Date Initiated by Firm: November 21, 2016
• Date Posted: January 19, 2017
• Recall Status: Terminated on March 07, 2017
• Recall Number: Z-1052-2017
• Recall Event ID: 76213
• 510(K)Number: K152467
• Product Classification: System, imaging, pulsed doppler, ultrasonic - Product Code IYN
• Product: Carestream Touch Prime, Catalog # 1738830, and Touch Prime XE, Catalog # 1738822, Ultrasound System; Diagnostic ultrasound imaging or fluid flow analysis of the human body
• Code Information: 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.
• Recalling Firm/ Manufacturer: Carestream Health Inc; 150 Verona St; Rochester NY 14608-1733
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Software design
• 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..
• Quantity in Commerce: US: 14 units; Foreign: 16 units
• Distribution: Worldwide Distribution - US including SC, GA, TX, OH, IA, NY and foreign distribution to Switzerland and Malaysia
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = IYN and Original Applicant = CARESTREAM HEALTH, INC.