Reported Nov 24, 2021 · Ongoing
Sensis/ Sensis Vibe systems with software VD1X as follows
Siemens Medical Solutions USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Medical Solutions USA, Inc · 40 Liberty Blvd · Malvern, PA · 19355-1418
Is this the product you have?
Sensis/ Sensis Vibe systems with software VD1X as follows
3 of 3 products
| Model / number | Product as published |
|---|---|
10764561 | (2) Sensis Vibe Hemo |
11007641 | (3)Sensis Vibe Combo |
11007642 | Intended Use: A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies |
- Lot codes and dates
- Serial NumbersExpanded Recall 10/27/21 (36
370 of 370 codes
15916159081031081031111591710304710304810317110318110318210318510319110319310330110317010322310322510324715939103313103315100413100414100417100402146121461310101610101710101910102010102210102910103110103210103618903159451594610335915931100263103424159531032741594115942103319103320103321103323103325103328103330103333103334103335103344100216103337
- units) Serial Numbers
1591510313710314410319610319815913103166103173123021103184103177103186103199103139103168102326103167103178103161103172141201034321023281552015522102060102062158071580610205710204910205110343110109510108915558
- Serial Numbers
- Amount recalled
- 403 units
Where it was sold
- Nationwide
Why it was recalled
System operator manual states that the system should be rebooted once, every 7 days. In some cases, users are not following these instructions and the system is running for more than 7 days. Under rare circumstances, this may result in a partial freeze of the user interface which would no longer update the vital signs
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Siemens Medical Solutions USA, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.