Sensis Vibe systems with software version recall
Sensis Vibe systems with software version VD15B-Intended to be used as a diagnostic and administrative tool supporting hemodynamic catheterizations…
Why was Sensis Vibe systems with software version recalled?
If the Sensis documentation functionality is used during adding of once-per-study reporting events (e.g., Type 1 events, as further defined in the administrator manual), the possibility exists that the application could crash.
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: 4056869010199 Serial Numbers: 18009 18010 18011 18014 18015 18016 19001 103584 103596 104064 106244 106245 ***Update 7/24/24*** S/N Added: 102183
- Product
- Sensis Vibe systems with software version VD15B-Intended to be used as a diagnostic and administrative tool supporting hemodynamic catheterizations…
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 12 units
- Distribution
- US Nationwide distribution in the states of CA, CT, FL, IA, KS, MA, MI, NJ, TX, VA.
- Recall date
- July 31, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)