FDA Device recall Z-1558-2022
AXIOM Sensis or Sensis Vibe Combo systems as follows: System Material # AXIOM Sensis, Combo 64 6623974
- FDA Device
- Class III
- terminated
- Published 2022-08-24
On 2022-08-24 the FDA classified a Class III recall of AXIOM Sensis or Sensis Vibe Combo systems as follows: System Material # AXIOM Sensis, Combo 64 6623974 by Siemens Medical Solutions Usa, citing 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 pa….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1558-2022 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2022-07-12 |
| Published | 2022-08-24 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
AXIOM Sensis or Sensis Vibe Combo systems as follows: System Material # AXIOM Sensis, Combo 64 6623974; AXIOM Sensis, Hemo LOW 6634633; AXIOM Sensis, Combo 32 6634641; AXIOM Sensis, EP 129 6634658; Sensis 10764561; Sensis Vibe Combo 11007642; Sensis recording system is intended to be used as a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology.
Reason
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
Identifiers
| code_info | 1.Sensis 10764561 UDI-DI:04056869010137 2. Sensis Vibe Combo 11007642 UDI-DI: 04056869010205 Serial Numbers:…1.Sensis 10764561 UDI-DI:04056869010137 2. Sensis Vibe Combo 11007642 UDI-DI: 04056869010205 Serial Numbers: 2022 2025 2032 2060 2113 2139 2154 2155 2186 2187 2201 2205 2224 2225 2227 2229 2269 2272 2276 2282 2291 2293 2294 2331 2332 2349 2350 2352 2403 2408 2425 2428 2442 2444 2500 2501 2515 2520 2521 2532 2552 2563 2576 2578 2581 2589 2608 2629 2744 3014 3015 3021 3037 3038 3041 3049 3050 3051 3057 3059 3060 3069 3075 3091 3097 3101 3103 3112 3128 3129 3134 3136 3140 3142 3166 3205 3206 3224 3226 3316 3321 3333 3352 3383 3390 3405 3406 3407 3408 3417 3432 3434 3437 3440 3464 3472 3475 3529 3534 3536 3564 3641 3642 3650 3653 3655 3660 3671 3676 4003 6101 6103 6110 6208 6622 6625 6631 6702 6727 8067 8068 20004 20015 20016 20023 20026 20045 20047 20048 20056 20062 20065 20109 20127 20139 20161 20162 20319 20321 20380 20383 20385 20391 2 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1558-2022%22
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