Recall Z-0683-2024— Siemens Medical Solutions USA, Inc
Class II · Ongoing
Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2023-11-29. It names one FDA 510(k) clearance: K223812. Product: Sensis Vibe Hemo. Reason: The possibility of the Sensis documentation functionality application to crash..
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-11-29
- Firm location
- Malvern, PA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Sensis Vibe Hemo
Reason for recall
The possibility of the Sensis documentation functionality application to crash.
Data sourced from openFDA. This site is unofficial and independent of the FDA.