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 diagn
Check against the official notice below — it lists the full affected range.
Siemens Medical Solutions USA, Inc. is recalling AXIOM Sensis and Sensis Vibe Combo imaging systems because the Signal Input Box can be mounted in non-default positions on an accessory rail, which creates safety hazards. When mounted outside the default position, patients may experience touch leakage current if they contact the Signal Input Box, or liquid may enter and damage the device. The recall affects 399 units in the United States and involves specific serial numbers manufactured between 2022 and 2023.
The recalled systems include the AXIOM Sensis Combo 64, AXIOM Sensis Hemo LOW, and AXIOM Sensis Combo 32 models. The systems have been distributed across the United States and numerous countries worldwide. The source document does not specify what remedy or corrective action an affected consumer should take.
Written by software from the official notice below. Not reviewed by a lawyer.
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
Reason for recall: 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 Distribution: US Nationwide Distribution Foreign: Albania Algeria Angola Argentina Armenia Aruba Australia Austria Azerbaijan Bahrain Bangladesh Belgium Bolivia Bosnia and Herzegovina Brunei Darussalam Bulgaria Cambodia Cameroon Canada Chile China Colombia Costa Rica Croatia Cuba Cyprus Czech Republic Denmark Ecuador Egypt El Salvador Estonia Ethiopia Finland France Georgia Germany Ghana Greece Guatemala Hong K Quantity: 399 units U.S. Lot/code info: 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 20392 20399 20407 20430 20448 20466 20525 20538 20546 20556 20557 20561 20573 20574 20575 20585 20598 20606 20618 20622 20660 21000 21034 21035 21037 21043 21051 21052 21056 21074 21076 21077 21095 21096 21098 21100 21102 21106 21109 21112 21226 21244 21297 21332 21334 21345 21346 21363 21383 21384 21388 21391 21399 21438 21452 21498 22000 22022 22037 22051 22217 22249 22251 22252 22267 22282 22312 22336 22341 22345 22357 22366 22406 22415 22423 22427 22436 22437 22438 22461 22462 22474 22480 22490 22512 22522 22523 22526 22528 22605 22612 22619 22623 22627 22628 22646 22648 22651 22652 22663 22667 22669 22670 22671 22681 22682 22688 22708 22720
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.