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Open, Classified

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

FDA Recall Z-1243-2022 · Posted 2022-06-06

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusOpen, Classified
Product CodeDQK
Date Initiated2022-04-13
Product Quantity443

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.

Firm Action

On April 13, 2022, the firm notified customers via an Urgent Medical Device Correction letter. Customers were informed of the software issues. the software in the affected systems will be updated to correct the issue. Siemens' service organization will contact customers to arrange a date to perform the corrective action. Please feel free to contact Siemens' service organization for an earlier appointment at 1-800-888-7436.

Root Cause

Software Design Change

Distribution Pattern

Domestic distribution nationwide.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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