Reported Jan 25, 2017 · Terminated
Carestream Touch Prime, Catalog # 1738830, and Touch Prime XE, Catalog # 1738822, Ultrasound System Diagnostic…
Carestream Health Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Carestream Health Inc · 150 Verona St · Rochester, NY · 14608-1733
Is this the product you have?
- Carestream Touch Prime, Catalog # 1738830, and Touch Prime XE, Catalog # 1738822, Ultrasound System Diagnostic ultrasound imaging or fluid flow analysis of the human body
- Lot codes and dates
- Serial NumbersUS
- units
1061121141161021103710381044105710671072107410791090
- OUS units
1005100610091011101510171018102010311041104210431045108110861089
- Amount recalled
- US: 14 units; Foreign: 16 units
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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