Siemens Healthcare recalls Epoc Host 2 devices with specific model numbers due to potential high oxygen recovery during quality control when adjusted for barometric pressure. Affected units include Canada, China, Japan, and refurbished models.
pO2 High Recovery in Quality Control When Adjusted for Barometric Pressure
Siemens Healthcare is recalling Epoc Host 2 devices with specific model numbers sold in Canada, China, Japan, and refurbished versions. The issue involves a potential high oxygen recovery reading during quality control testing when adjusted for barometric pressure, which could lead to inaccurate results.
The device may show high oxygen recovery readings during quality control testing when barometric pressure is adjusted. This could lead to inaccurate test results, but it does not pose a direct physical risk to users.
Users of Epoc Host 2 devices with model numbers listed in the recall (e.g., 10736387 for Canada) are affected. Laboratory staff and healthcare professionals using these devices for medical testing are most at risk due to potential inaccurate results.
Check for model numbers like 10736387 (Canada), 10736388 (China), or 10736390 (Japan) on the device label. Refurbished models with the same model numbers are also included in the recall.
Look for model numbers on the device label, such as 10736387 for Canada or 10736388 for China.
The model number for the Epoc Host 2 in Canada is 10736387.
Yes, refurbished Epoc Host 2 devices with model numbers like 10736393 (Canada) or 11413524 (US) are included in the recall.
The recall addresses potential inaccurate test results, not a direct physical risk to users. There is no mention of injury or serious harm in the official notice.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1214-2023 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1214-2023 from Siemens 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.