Reported Aug 24, 2022 · Terminated
AXIOM Sensis or Sensis Vibe Combo systems as follows
Siemens Medical Solutions USA, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.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?
AXIOM Sensis or Sensis Vibe Combo systems as follows
6 of 6 products
| Model / number | Product as published |
|---|---|
6623974 | AXIOM Sensis, Combo 64 |
6634633 | AXIOM Sensis, Hemo LOW |
6634641 | AXIOM Sensis, Combo 32 |
6634658 | AXIOM Sensis, EP 129 |
10764561 | Sensis |
11007642 | Sensis Vibe Combo |
- Lot codes and dates
- 1
- Sensis 10764561 UDI-DI04056869010137 2
- Sensis Vibe Combo 11007642 UDI-DI04056869010205
- Serial Numbers
399 of 399 codes
202220252032206021132139215421552186218722012205222422252227222922692272227622822291229322942331233223492350235224032408242524282442244425002501251525202521253225522563257625782581258926082629274430143015302130373038304130493050305130573059
- Amount recalled
- 399 units U.S.
Where it was sold
- Nationwide
- GA
Why it was recalled
The Sensis Signal Input Box provides hooks as a milled item on the bottom of the box support the possibility of mounting the Signal Input Box on an accessory rail (e.g., at the patient table), In the event the mounting position deviates from the default position, the following are possible: Patient touching the Signal Input Box may result in a touch leakage current to the patient; Spillage of liquid entering the Signal Input Box
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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