Carestream Touch Prime, Catalog Number 1738830, and Carestream Touch Prime XE, Catalog Number 1738822 --- Common Name: T

FDA device recall Z-2217-2016 · posted 2016-07-18 · Terminated

Recall details

Recalling firm

Carestream Health Inc

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.

Action taken

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.

Root cause

Software design

Status

Terminated

Product code

IYN

Quantity affected

7 Units (US: 5 units, OUS: 2 units)

Distribution

Worldwide Distribution: US Distribution to states of: GA, IA, and TX; and country of: Italy.

Date initiated

2016-07-08

Date posted

2016-07-18

Date terminated

2017-05-02

Location

Rochester, NY

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