Carestream Touch Ultrasound Recalled for Volume Measurement Software Error
Carestream Health is recalling Touch Prime and Touch Prime XE ultrasound units because a software issue may cause anatomy volume measurements to be overestimated.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (diagnostic medical device) where the software error could lead to inaccurate clinical data, but no injuries or illnesses have been reported.
Plain-English summary
Carestream Health Inc is recalling 7 units of Carestream Touch Prime (Catalog Number 1738830) and Carestream Touch Prime XE (Catalog Number 1738822) diagnostic ultrasound systems. The recall involves specific serial numbers for both models, with 5 units distributed in the United States (Georgia, Iowa, and Texas) and 2 units distributed in Italy.
The recall is due to a software issue related to the generic volume measurement functionality. This defect could result in the volume of the subject anatomy being overestimated, causing measurement results to appear enlarged or distended when the anatomy is actually not. The FDA has classified this as a Class II recall.
Healthcare providers who have these specific units should contact Carestream Health Inc for instructions on how to resolve the software issue. Consumers are not directly affected by this recall as the devices are used by medical professionals for diagnostic imaging.
The recalled product
- Product
- Carestream Touch Prime, Catalog Number 1738830, and Carestream Touch Prime XE, Catalog Number 1738822 --- Common Name: Touch Ultrasound Diagnostic ultrasound imaging or fluid flow analysis of the human body
- Manufacturer
- Carestream Health Inc
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Touch Prime Serial Numbers: 1037
- 1038
- -- Touch Prime XE Serial Numbers: 1021
- 1079
- 1067
- 1041
- 1043
Distribution
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