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Outset Medical, Inc.
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Type Company Card addedAugust 10 Threat lists flagged Reviews1
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Threat lists · flagged Product safety recall
Official safety regulators published alerts about a product of this kind.
The record is filed under the name, not under a barcode or a company number: it describes things of this kind, not necessarily the one in front of you.
Alerts on record3 HazardBlood leak sensor, a component of hemodialysis device, may show decreased sensitivity, at the lowest level, specified as 0.35 mL/min blood leak rate, which could delay triggering the ALARM_D First alertMarch 6, 2024 Latest alertAugust 1, 2024 On our lists sinceAugust 10, 2026
What to do: Check the maker, the batch and the date of the exact item you have — the alert is about this kind of product.
Where this came from: openFDA device recalls — An official government safety register — product recalls and safety alerts.
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Reviews · 1
Outset Medical, Inc. stands in the dialysis equipment space, so it is aimed at a very specific medical world rather than general health care chatter. By our assessment, its strongest point is that it is clearly about real hardware and treatment workflows, not vague wellness branding. The trade-off is obvious: this is specialist, regulated equipment, so the audience is narrow and the product lives inside hospitals and clinics instead of everyday life. In practice that means a company like this is judged on reliability, service, and fit with clinical routines more than on style. It sits beside other medical-device makers, not consumer health apps, and the name says that much already.
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