Z-2217-2016Class II

Carestream Touch Prime, Catalog Number 1738830, and Carestream Touch Prime XE, Catalog Number 1738822...

Name: Z-2217-2016 Carestream Touch Prime, Catalog Number 1738830, and Carestream Touch Prime XE, Catalog Number 1738822...
Creator: Carestream Health Inc
Published: 2016-07-08
License: https://open.fda.gov/license/

Eastman Kodak Company / initiated 2016-07-08 / Terminated / root cause: software

FDA source

Carestream Health Inc began a recall of Carestream Touch Prime, Catalog Number 1738830, and Carestream Touch Prime XE, Catalog Number 1738822 --- Common Name: Touch Ultrasound Diagnostic ultrasound... on 2016-07-08. FDA classified it as Class II and gives the reason as "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...". 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-2217-2016
Classification: Class II
Status: Terminated
Initiated: 2016-07-08
Posted: 2016-07-18
Terminated: 2017-05-02
Recalling firm: Eastman Kodak Company
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
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
Reason for recall: 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.
Root cause tag: software
FDA root cause: Software design
Action: The firm, Carestream Health Inc., sent an "URGENT: MEDICAL DEVICE CORRECTION" Letter dated 7/7/2016 and response form the end users/customers on 7/8/2016 via Certified Mail, Return Receipt Requested. The letter described the product, problem and actions to be taken. The Customers were instructed not use the generic volume measurement tool until Carestream has updated the system software. In the interim, calculate volumes by using the specific volume tool from the desired calculation package. 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. Carestream has created a software update for Touch Ultrasound to resolve this issue and will update your software. Carestreams representative will contact you and schedule a convenient time to upgrade the software. For questions or concerns, please contact the Carestream Customer Care Center in the US at 1-800-328-2910 (available on a 24/7 basis). Outside of the US, please call your local Service support number.
Quantity in commerce: 7 Units (US: 5 units, OUS: 2 units)
Distribution: Worldwide Distribution: US Distribution to states of: GA, IA, and TX; and country of: Italy.
Product codes and lots: Touch Prime Serial Numbers: 1037, 1038; -- Touch Prime XE Serial Numbers: 1021, 1079, 1067, 1041, 1043

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2217-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2217-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-27	2016-07-18

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)