Recall Z-0499-2022 ยท DQK Computer, Diagnostic, Programmable
Siemens Medical Solutions USA, Inc
1. Sensis, material # 10764561; UDI: 04056869010137 2. Sensis Vibe Hemo, material # 11007641; UDI: 04056869010199 3. Sensis Vibe Combo, material # 11007642; UDI: 04056869010205 The Sensis recording system is a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac, interventional Radiology, and surgical studies.
| Date | Jan 14, 2022 (initiated Nov 23, 2021) |
| Status | Open, Classified |
| Reason | Software error which affects Sensis Vibe Hemo, Sensis and Sensis Vibe Combo systems with software version VD12A, which could cause possible hazard to patients, operators, or other persons and equipment. Under certain sporadic circumstances, the CO (Cardiac Output) measurement using the Thermodilution method will temporarily no longer be possible. |
| Root cause | Software design |
| Action | On November 23, 2021, Siemens Healthineers issued an Urgent Medical Device Correction notice to all users of Sensis Vibe Hemo systems, Sensis and Sensis Vibe Combo systems with software version VD12A. Please make sure that an alternative system can be used to provide treatment. Please notify and instruct accordingly all the staff at your organization who need to be aware of this notice and will comply with the recommendations therein. Siemens will provide a software update to all affected customers which will correct the issue via Update Instruction AX077/21/S. Siemens service organizati |
| Quantity | 1047 |
| Distribution | US Nationwide distribution in the states of AK, AL, AR, AZ, CA, FL, GU, HI, IA, IL, IN, KS, KY, MA, MI, MO, MS, NC, NE, NJ, NY, OH, OK,PA, PR, SD, TN, TX, WA, WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150493 | Sensis Siemens Medi Cal Solutions, Inc., Jun 30, 2015 |