Sensis, Programmable Diagnostic Computer, Model Nos. 6623974 6634633 6634658 6648153 6648161 10140973 10764561 10765502 10910620
Check against the official notice below — it lists the full affected range.
Siemens Medical Solutions USA is recalling 443 AXIOM Sensis, Sensis Lite, and related diagnostic computer systems distributed nationwide due to three potential software issues. These software problems could prevent treatment from continuing on the affected system, which may create a hazardous situation for patients if they cannot be transferred to an alternate system to continue their treatment.
The recall affects specific serial numbers across multiple model numbers including 6623974, 6634633, 6634658, 6648153, 6648161, 10140973, 10764561, 10765502, and 10910620. The source document does not specify what actions affected consumers or medical facilities should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Siemens has become aware of three potential software issues with AXIOM Sensis or Sensis/ Sensis Lite systems. This may lead to a hazardous situation for patients if treatment cannot be continued on the system and treatment needs to be continued on an alternate system.
Reason for recall: Siemens has become aware of three potential software issues with AXIOM Sensis or Sensis/ Sensis Lite systems. This may lead to a hazardous situation for patients if treatment cannot be continued on the system and treatment needs to be continued on an alternate system. Distribution: Domestic distribution nationwide. Quantity: 443 Lot/code info: UDI-DI: 04056869010137 Material Serial 6623974 40108 6623974 41202 6623974 41017 6623974 42308 6623974 6101 6623974 41021 6623974 6110 6623974 6622 6623974 6727 6634633 3021 6634633 2272 6634633 2563 6634633 2589 6634633 20380 6634633 3112 6634633 2291 6634633 3405 6634633 3406 6634633 3440 6634633 3407 6634633 3408 6634633 3437 6634633 22267 6634633 21334 6634633 3417 6634633 3564 6634633 2060 6634633 2154 6634633 2155 6634633 2201 6634633 3037 6634633 3038 6634633 3041 6634633 3166 6634633 3224 6634633 3226 6634633 3352 6634633 3534 6634633 3536 6634633 20102 6634633 20134 6634633 20137 6634633 20149 6634633 20314 6634633 22688 6634633 2520 6634633 2521 6634633 2506 6634633 2709 6634633 2739 6634633 3072 6634633 21212 6634633 2552 6634633 2744 6634633 3060 6634633 20062 6634633 20574 6634633 2442 6634633 2444 6634633 2500 6634633 2501 6634633 2025 6634633 2276 6634633 2408 6634633 3622 6634633 3650 6634633 3653 6634633 3670 6634633 3671 6634633 3676 6634633 2578 6634633 22427 6634633 20448 6634633 21034 6634633 21035 6634633 21043 6634633 22336 6634633 21037 6634633 21051 6634633 21052 6634633 21095 6634633 21100 6634633 21102 6634633 21438 6634633 22022 6634633 2515 6634633 3390 6634633 2282 6634633 2331 6634633 2332 6634633 20321 6634633 20045 6634633 20047 6634633 3333 6634633 20598 6634633 2203 6634633 3091 6634633 3097 6634633 3059 6634633 3472 6634633 22671 6634633 2434 6634633 20525 6634633 20556 6634633 20557 6634633 2022 6634633 2032 6634633 2629 6634633 20392 6634
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.