Reported Apr 24, 2024 · Ongoing
Masimo Rad-G, Pulse Oximeter with temperature (W/Sensor), REF:9210, Rx Only,
Masimo Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Masimo Corporation · 52 Discovery · Irvine, CA · 92618-3105
Is this the product you have?
- Masimo Rad-G, Pulse Oximeter with temperature (W/Sensor)
- REF9210, Rx Only
- Lot codes and dates
- UDI(01)00843997008013/Serial
- Numbers
443 of 443 codes
600008385560000839856000083987600008399260000839966000084000600008400360000840056000084009600008401060000840126000084013600008401560000840166000084038600008404660000840526000084057600008405960000840606000084064600008406760000840716000084080600008413460000841406000084165600008417560000841846000084192600008419660000841976000084200600008420160000842026000084207600008426660000842786000084279600008428060000842826000084284600008428560000842866000084287600008428860000842896000084296600008429960000843066000084310600008431360000843146000084315600008431760000843186000084319600008432160000843256000084326
- Amount recalled
- 443 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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