GE Healthcare recalls CARESCAPE PDM SpO2 monitors that may freeze saturation values without power down. Affected models include SA3, SPX with specific part numbers. No action needed if device functions normally.
Masimo SpO2 Saturation Values can become frozen after an extended length of use without a power down.
GE Healthcare is recalling certain CARESCAPE PDM SpO2 monitors that can freeze saturation readings after extended use without a power cycle. This could lead to inaccurate blood oxygen measurements, which might affect patient monitoring decisions.
The monitor may freeze saturation values after extended use without a power down cycle. This could cause inaccurate blood oxygen readings, potentially leading to incorrect patient monitoring decisions. However, the device remains functional if it does not freeze.
Healthcare professionals using the affected CARESCAPE PDM SpO2 monitors for patient monitoring. Patients using these monitors are at low risk if the device functions normally.
Check for product codes SA3 or SPX on the device. Affected models include specific part numbers listed in the recall notice. The device may have a software kit or field replaceable unit with the listed part numbers.
If the monitor displays normal saturation values and functions without freezing, no action is needed.
No. The recall states that if the device functions normally without freezing, no action is needed.
Affected part numbers include SA3, SPX, and specific model numbers like 2042084-001, 2094504-001, and others listed in the recall notice.
The recall indicates a low risk as the device may still function normally if it does not freeze.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2139-2021 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-2139-2021 from GE Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
