Recall Z-1339-2020 ยท KPR System, X-Ray, Stationary
Siemens Medical Solutions USA, Inc
Ysio Max, model no. 10762470 - Product Usage: The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures f the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures,
| Date | Jan 8, 2020 |
| Status | Terminated |
| Reason | A software bug may lead to one image to be assigned to two different patients, which could potentially affect medical diagnosis. |
| Root cause | Software design |
| Action | On January 8, 2020, the firm notified customers of the product issue via an Urgent Medical Device Correction letter. Customers were instructed to ensure that the image displayed after acquisition is a newly acquired image and belongs to the current patient. If the error occurs and a previously acquired image is duplicated, the user should delete the image and contact Siemens Customer Service at 1-800-888-7436 to report the incident. Siemens Healthineers will correct the error with a field software update which will be available beginning January 2020. Your local Siemens Healthineers Service |
| Quantity | 507 |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133259 | YSIO MAX Siemens Medical Solutions USA, Inc., Jan 24, 2014 |