Recall Z-0748-2022 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Siemens Medical Solutions USA, Inc.
Diagnostic Ultrasound System, ACUSON Juniper, UDI: (01)04056869152059, Model: 11335791, Rx, CE Ultrasound imaging system intended for the following applications: Vascular, Abdominal, Neonatal, Echocardiographical, Pediatric, Small Parts, Musculoskeletal, Obstetrical, Gyneological, Intraoperative, and Urological applications using different ultrasound transducers for different applications.
| Date | Jan 19, 2022 |
| Status | Open, Classified |
| Reason | The clip store function in the ultrasound imaging system does not work when the system has a disk full error. This could cause a delay in treatment if the ultrasound system is unable to save clips as study documentation during a high risk procedure, such as a stress echo exam. |
| Root cause | Software design |
| Action | The firm, Siemens Healthineers, sent "URGENT MEDICAL DEVICE SAFETY CORRECTION" Letters Juniper 1.0 (VA10D/VA10E/VA10F) to affected customers via Siemens update program US026/21/S informing them of the issue and advising them the firm will correct this issue with a free-of-charge software update to their ACUSON Juniper ultrasound system. The customers were instructed to do the following: Check the available storage on the ultrasound system prior to starting a study where clips are vital to the documentation, such as stress echo. If available, use a different ultrasound system capable of perfo |
| Quantity | 2846 |
| Distribution | Worldwide distribution: US (nationwide) and countries of: Algeria, Andorra, Argentina, Australia, Austria, Bangladesh, Belgium, Bosnia Herzeg, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Faroe Islands, France, Germany, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K201130 | ACUSON Juniper Diagnostic Ultrasound System Siemens Medical Solutions USA, Inc., May 26, 2020 |