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Terminated

Xper Flex Cardio Physiomonitoring System, Software versions 1.5.16.0322 and 1.6.1.0390, Model Numbers 453564241901, 453564241911, 453564483321, 453564483331, 453564621791, 453564621801, 453564669081

FDA Recall Z-0614-2019 · Posted None

Recalling FirmPhilips Electronics North America Corporation
Recall StatusTerminated
Product CodeDQK
Date Initiated2018-11-15
Date Terminated2024-09-20
Product Quantity651 units

Reason for Recall

There are 3 issues: 1) Under certain conditions, real time waveforms may not be accurately plotted or displayed. 2) The oxygen saturation (SpO2) numeric value displayed on the device may freeze. 3) In auto cycle mode, if the NIBP communication is lost, the pump would not cycle and the non-invasive blood pressure (NIBP) numeric value displayed on the device would not update.

Firm Action

The firm initiated the recall on X by letter. The letter explained the issues, potential risk, and provided workarounds for the consignee to use until the new software is ready for release.

Root Cause

Software Design Change

Distribution Pattern

worldwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K101571XPER INFORMATION MANAGEMENT AND FLEX CARDIO PHYSIOMONITORING SYSTEMSWitt Biomedical Corp · 2010-10-26

Official Source

View FDA Recall →

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

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