Reported Jul 27, 2016 · Terminated
Carestream Touch Prime, Catalog Number 1738830, and Carestream Touch Prime XE, Catalog Number 1738822 --- Common Name:…
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 Number 1738830, and Carestream Touch Prime XE
- Catalog Number 1738822 --- Common NameTouch Ultrasound Diagnostic ultrasound imaging or fluid flow analysis of the human body
- Lot codes and dates
- Touch Prime Serial Numbers
10371038--
- Touch Prime XE Serial Numbers
10211079106710411043
- Touch Prime Serial Numbers
- Amount recalled
- 7 Units (US: 5 units, OUS: 2 units)
Where it was sold
Why it was recalled
A software issue related to the generic volume measurement functionality could result in the volume of the subject anatomy being overestimated. For example, measurement results of the anatomy may appear enlarged or distended when it actually is not.
This product could cause temporary or reversible health problems — stop using it.
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