FDA Device recall Z-1052-2017
Carestream Touch Prime, Catalog # 1738830, and Touch Prime XE, Catalog # 1738822, Ultrasound System Diagnostic ultrasound imaging or fluid…
- FDA Device
- Class II
- terminated
- Published 2017-01-25
On 2017-01-25 the FDA classified a Class II recall of Carestream Touch Prime, Catalog # 1738830, and Touch Prime XE, Catalog # 1738822, Ultrasound System Diagnostic ultrasound imaging or fluid… by Carestream Health, citing 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 result….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1052-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-11-21 |
| Published | 2017-01-25 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Carestream Health |
| Distribution | GA, IA, NY, OH, SC, TX |
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
Reason
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.
Identifiers
| code_info | Serial Numbers: US units: 106, 112, 114, 116, 1021, 1037, 1038, 1044, 1057, 1067, 1072, 1074, 1079, 1090; OUS units: 10…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, 1018, 1020, 1031, 1041, 1042, 1043, 1045, 1081, 1086, 1089. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1052-2017%22
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