Z-1052-2017Class II

Carestream Touch Prime, Catalog # 1738830, and Touch Prime XE, Catalog # 1738822, Ultrasound System...

Name: Z-1052-2017 Carestream Touch Prime, Catalog # 1738830, and Touch Prime XE, Catalog # 1738822, Ultrasound System...
Creator: Carestream Health Inc
Published: 2016-11-21
License: https://open.fda.gov/license/

Eastman Kodak Company / initiated 2016-11-21 / Terminated / root cause: software

FDA source

Carestream Health Inc began a recall of Carestream Touch Prime, Catalog # 1738830, and Touch Prime XE, Catalog # 1738822, Ultrasound System Diagnostic ultrasound imaging or fluid flow analysis of the... on 2016-11-21. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1052-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-21
Posted: 2017-01-19
Terminated: 2017-03-07
Recalling firm: Eastman Kodak Company
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
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
Reason for recall: 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.
Root cause tag: software
FDA root cause: Software design
Action: Carestream sent an URGENT: MEDICAL DEVICE CORRECTION Letter dated November 17, 2016, with a Consignee Notification Acknowledgement (HRA # MA-2016-019) to all affected US consignees via UPS on November 21, 2016. The letter identified the product, the problem, and the action to be taken by the consignee Action to be Taken: When reviewing the worksheet, if a zero value is observed and that calculation field needs to be changed, the calculation needs to be deleted from the worksheet. Once deleted, the user needs to acquire a new calculation from a clinical image. Carestream is currently validating a fix for this problem and your local service representative will be contacting you within the next few weeks to arrange to upgrade your software. If you have any questions or concerns, please contact the Carestream Customer Care Center in the U.S. at 1-800-328-2910, available 7 days per week on a 24 hour basis. Outside of the U.S., please call your local Service support number. If you have distributed the device outside your facility, please alert your customer(s) of this field correction and contact Carestream Customer Care Center as listed above..
Quantity in commerce: US: 14 units; Foreign: 16 units
Distribution: Worldwide Distribution - US including SC, GA, TX, OH, IA, NY and foreign distribution to Switzerland and Malaysia
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1052-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1052-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-25	2017-01-19

Product code IYN

K152467Class IITouch UltrasoundCarestream Health, Inc. / cleared 2015-12-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)