Sensis Vibe Combo with software version VD12A. A recall: Software Issue
Sensis Vibe Combo with software version VD12A. A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology…
Why was Sensis Vibe Combo with software version VD12A. A recalled?
Sensis/Sensis Vibe SoftwareVD12A, the ComboBox may encounter a disconnect of its communication during the first patient examination of the day or after a longer period of inactivity to the Sensis Vibe system resulting in no vital signs being available.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 04056869010205 Serial Numbers: 123021, 123055, 123056, 123058, 122042, 123004, 122006, 122026, 122029, 123047, 123053, 122011, 121014.
- Product
- Sensis Vibe Combo with software version VD12A. A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology…
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 13 units
- Distribution
- US Nationwide Distribution AZ FL KY MI OH PR TX
- Recall date
- July 27, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)