Recall Z-1052-2017 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Carestream Health Inc
Carestream Touch Prime, Catalog # 1738830, and Touch Prime XE, Catalog # 1738822, Ultrasound System Diagnostic ultrasound imaging or fluid flow analysis of the human body
| Date | Jan 19, 2017 (initiated Nov 21, 2016) |
| Status | Terminated |
| 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 cor |
| Root 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 validatin |
| Quantity | US: 14 units; Foreign: 16 units |
| Distribution | Worldwide Distribution - US including SC, GA, TX, OH, IA, NY and foreign distribution to Switzerland and Malaysia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152467 | Touch Ultrasound Carestream Health, Inc., Dec 9, 2015 |