# FDA recall Z-1243-2022

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2022-04-13.

## Product

Sensis, Programmable Diagnostic Computer, Model Nos.	6623974                      6634633  6634658                      6648153  6648161                      10140973  10764561                    10765502  10910620

## 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.

## Key facts

- **Recall number:** Z-1243-2022
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-04-13
- **Report date:** 2022-06-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Malvern, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1243-2022

## Citation

> AI Analytics. FDA recall Z-1243-2022. Retrieved 2026-08-12 from https://api.ai-analytics.org/recall/Z-1243-2022. Source: US FDA. Licensed CC0.

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