1. Sensis, material # 10764561; UDI: 04056869010137 2. Sensis Vibe Hemo, material # 11007641; UDI: 04056869010199 3. Sen
FDA device recall Z-0499-2022 · posted 2022-01-14 · Open, Classified
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- 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.
- Action taken
- 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 organization will contact you to arrange a date to perform this corrective action. Please feel free to contact Siemens service organization for an earlier appointment at 1-800-888-7436.
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- DQK
- Quantity affected
- 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.
- Date initiated
- 2021-11-23
- Date posted
- 2022-01-14
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Sensis (K150493) | Siemens Medi Cal Solutions, Inc. | 2015-06-30 |