PlainRecalls
FDA Devices Moderate Class II Terminated

Carestream Touch Prime, Catalog # 1738830, and Touch Prime XE, Catalog # 1738822, Ultrasound System Diagnostic ultrasound imaging or fluid flow analysis of the human body

Reported: January 25, 2017 Initiated: November 21, 2016 #Z-1052-2017

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

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.

Details

Recalling Firm
Carestream Health Inc
Units Affected
US: 14 units; Foreign: 16 units
Distribution
Worldwide Distribution - US including SC, GA, TX, OH, IA, NY and foreign distribution to Switzerland and Malaysia
Location
Rochester, NY

Frequently Asked Questions

What product was recalled?
Carestream Touch Prime, Catalog # 1738830, and Touch Prime XE, Catalog # 1738822, Ultrasound System Diagnostic ultrasound imaging or fluid flow analysis of the human body. Recalled by Carestream Health Inc. Units affected: US: 14 units; Foreign: 16 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on January 25, 2017. Severity: Moderate. Recall number: Z-1052-2017.