Recall Z-2217-2016 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Carestream Health Inc
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
| Date | Jul 18, 2016 (initiated Jul 8, 2016) |
| Status | Terminated |
| Reason | 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 | 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 fiel |
| Quantity | 7 Units (US: 5 units, OUS: 2 units) |
| Distribution | Worldwide Distribution: US Distribution to states of: GA, IA, and TX; and country of: Italy. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152467 | Touch Ultrasound Carestream Health, Inc., Dec 9, 2015 |