Reported Mar 15, 2023 · Ongoing
epoc Host 2 as follows
Siemens Healthcare Diagnostics Inc.
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: Siemens Healthcare Diagnostics Inc · 2 Edgewater Dr · Norwood, MA · 02062-4637
Is this the product you have?
epoc Host 2 as follows
7 of 7 products
| # | Product as published |
|---|---|
| 1 | Refurbished 10736393 epoc Host 2, Canada |
| 2 | Refurbished 10736394 epoc Host 2, Japanese |
| 3 | Refurbished 10736395 epoc Host 2, Chinese |
| 4 | Refurbished 10736433 epoc Host 2, US (MC55X) 11413524 epoc Host 2, ROW (MC55X) 11413528 epoc Host 2, India (MC55X) 11413541 epoc Host 2, China (MC55X) 11413542 epoc Host 2, Japan (MC55X) 11413543 epoc Host 2 (MC55X) - US |
| 5 | Refurbished 11413601 "epoc Host 2 (MC55X) - ROW -Refurbished" 11413602 epoc Host 2 (MC55X) - India |
| 6 | Refurbished 11413603 epoc Host 2 (MC55X) - Japan |
| 7 | Refurbished 11413604 |
- Lot codes and dates
17 of 17 products
Products covered by this recall # Barcodes Product as published 1 0080970805289837.3/41.1 Product Description Siemens Material Number (SMN) Unique Device Identification (UDI-DI) epoc Host 2 10736387 00809708052898 2 00809708069117epoc Host 2, Canada 10736388 00809708069117 3 00809708097219epoc Host 2, China 10736389 00809708097219 4 00809708075576epoc Host 2, Japan 10736390 00809708075576 5 00809708053901epoc Host 2, Refurbished 10736393 00809708053901 6 00809708069124epoc Host 2, Canada, Refurbished 10736394 00809708069124 7 00809708075583epoc Host 2, Japanese, Refurbished 10736395 00809708075583 8 00809708097226epoc Host 2, Chinese, Refurbished 10736433 00809708097226 9 00630414606460epoc Host 2, US (MC55X) 11413524 00630414606460 10 00630414606378epoc Host 2, ROW (MC55X) 11413528 00630414606378 11 00630414608617epoc Host 2, India (MC55X) 11413541 00630414608617 12 00630414608624epoc Host 2, China (MC55X) 11413542 00630414608624 13 00630414608532epoc Host 2, Japan (MC55X) 11413543 00630414608532 14 00630414615004epoc Host 2 (MC55X) - US - Refurbished 11413601 00630414615004 15 00630414614885"epoc Host 2 (MC55X) - ROW - Refurbished" 11413602 00630414614885 16 00630414614762epoc Host 2 (MC55X) - India - Refurbished 1413603 00630414614762 17 00630414614892epoc Host 2 (MC55X) - Japan - Refurbished 11413604 00630414614892. - Amount recalled
- 22,156 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- GA
Why it was recalled
pO2 High Recovery in Quality Control When Adjusted for Barometric Pressure
This product could cause temporary or reversible health problems — stop using it.
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