GE Healthcare CARESCAPE PDM SpO2 Monitor: Frozen Saturation Values After Extended Use
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.
Lower-risk recall
Masimo SpO2 Saturation Values can become frozen after an extended length of use without a power down.
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What happened, in plain English
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. Read more at govinfonow.com/recall/62497-ge-healthcare-carescape-pdm-spo2-monitor-frozen-saturation-values-after.
Source Summary by GovInfoNow · govinfonow.com/recall/62497-ge-healthcare-carescape-pdm-spo2-monitor-frozen-saturation-values-after · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2139-2021
Cite this page
“GE Healthcare CARESCAPE PDM SpO2 Monitor: Frozen Saturation Values After Extended Use.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62497-ge-healthcare-carescape-pdm-spo2-monitor-frozen-saturation-values-after. Based on FDA recall #Z-2139-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2139-2021%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
GE Healthcare- Category
Medical device
What to do — step by step
Check Device Function
If the monitor displays normal saturation values and functions without freezing, no action is needed.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “worldwide distribution US nationwide, Albania, Algeria, Argentina, Australia, Austria, Bahamas, Bahrain, Belgium, Bermuda, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 2 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #Z-2139-2021 (May 21, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2139-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.