Device Recall Carestream Touch Prime 의 리콜

Recall

74652

Class 2

Z-2217-2016

2016-07-08

2016-07-18

Terminated

United States

2017-05-02

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148112

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.

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.