Carestream Ultrasound Systems Recalled for Software Measurement Unit Error
Carestream Health Inc. is recalling Touch Prime and Touch Prime XE ultrasound systems due to a software error that may display incorrect measurement units.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a software error that could lead to incorrect diagnostic data, but no injuries or illnesses are reported in the source text.
Plain-English summary
Carestream Health Inc. is recalling specific units of the Carestream Touch Prime and Touch Prime XE diagnostic ultrasound systems. The recall involves 14 units distributed in the United States and 16 units distributed in Switzerland and Malaysia.
The recall is due to a software error that can occur when a user corrects a measurement value of 0 in a report. In this specific scenario, the resulting measurement unit is not displayed, leading the user to assume the value is in centimeters. However, the system actually calculates the value in millimeters. This discrepancy can cause incorrect results when the value is used in average calculations or when minimum and maximum values are displayed.
Healthcare facilities and users with the affected serial numbers should contact Carestream Health Inc. for instructions on how to resolve the software issue. The affected serial numbers for US units are 106, 112, 114, 116, 1021, 1037, 1038, 1044, 1057, 1067, 1072, 1074, 1079, and 1090. The affected serial numbers for foreign units are 1005, 1006, 1009, 1011, 1015, 1017, 1018, 1020, 1031, 1041, 1042, 1043, 1045, 1081, 1086, and 1089.
The recalled product
- Product
- Carestream Touch Prime, Catalog # 1738830, and Touch Prime XE, Catalog # 1738822, Ultrasound System 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 (20)
- Serial Numbers: US units: 106
- 112
- 114
- 116
- 1021
- 1037
- 1038
- 1044
- 1057
- 1067
- 1072
- 1074
- 1079
- 1090
- OUS units: 1005
- 1006
- 1009
- 1011
- 1015
- 1017
Distribution
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