X-Smart Pro / X-Smart Pro+

Description of Event or Problem

It was reported that a X-Smart Pro / X-Smart Pro+ had incorrect measurement; patient outcome is unknown and additional information is being requested.

Additional Manufacturer Narrative

There has been a previous report received where this malfunction resulted in a serious injury. Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such. As such, this event is reportable per 21CFR Part 803.The device is available for evaluation, though has not been returned as of this report. Evaluation results will be submitted as they become available.