Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported March 15, 2023
epoc Host 2 as follows: Product SMN epoc Host 10736387 epoc Host 2, Canada 10736388 epoc Host 2, China 10736389 epoc Host 2, Japan 10736390 epoc Host 2, Refurbished 10736393 epoc Host 2, Canada, Refurbished 10736394 epoc Host 2, Japanese, Refurbished 10736395 epoc Host 2, Chinese, 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) 1141
pO2 High Recovery in Quality Control When Adjusted for Barometric Pressure
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Siemens Healthcare Diagnostics Inc recalled epoc Host 2 as follows: Product SMN epoc Host 10736387 epoc Host 2, … - a moderate-severity action.
epoc Host 2 as follows: Product SMN epoc Host 10736387 epoc Host 2, … was recalled by Siemens Healthcare Diagnostics Inc in March 15, 2023. Reason: pO2 High Recovery in Quality Control When Adjusted for Barometric Pressure. Check the official notice for the remedy. Verify recall #Z-1214-2023 with the FDA Devices before acting.
The recall
Siemens Healthcare Diagnostics Inc issued this moderate-severity FDA Devices recall-pO2 High Recovery in Quality Control When Adjusted for Barometric Pressure.
- Moderate
- severity level
- 22K units
- affected scope
- Class II
- classification
- March 15, 2023
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1214-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1214-2023) was formally reported on March 15, 2023, with the manufacturer initiating the action on December 12, 2022. It is classified under Moderate severity (Class II), with a current status of Ongoing. Siemens Healthcare Diagnostics Inc is listed as the recalling firm, operating out of Norwood, MA. Federal records list the affected scope as 22,156 units.
The documented reason for this recall is: pO2 High Recovery in Quality Control When Adjusted for Barometric Pressure Distribution data in the federal record shows the product reached: Nationwide Foreign: Algeria Argentina Australia Austria Bahrain Belarus Belgium Bolivia Brazil Cambodia Canada Chile China Colombia Croatia Czech Republic Denmark Ecuador Egypt Estonia Finland France Fren.Polynesia Geor…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
22,156 units
Related Recalls
6
3 from same agency
Product description
epoc Host 2 as follows: Product SMN epoc Host 10736387 epoc Host 2, Canada 10736388 epoc Host 2, China 10736389 epoc Host 2, Japan 10736390 epoc Host 2, Refurbished 10736393 epoc Host 2, Canada, Refurbished 10736394 epoc Host 2, Japanese, Refurbished 10736395 epoc Host 2, Chinese, 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 - Refurbished 11413601 "epoc Host 2 (MC55X) - ROW -Refurbished" 11413602 epoc Host 2 (MC55X) - India - Refurbished 11413603 epoc Host 2 (MC55X) - Japan - Refurbished 11413604
Reason for recall
pO2 High Recovery in Quality Control When Adjusted for Barometric Pressure
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1214-2023 |
| Date reported | March 15, 2023 |
| Date initiated | December 12, 2022 |
| Recalling firm | Siemens Healthcare Diagnostics Inc |
| Firm location | Norwood, MA |
| Affected scope | 22,156 units |
| Distribution | Nationwide Foreign: Algeria Argentina Australia Austria Bahrain Belarus Belgium Bolivia Brazil Cambodia Canada Chile China Colombia Croatia Czech Republic Denmark Ecuador Egypt Estonia Finland France Fren.Polynesia Georgia Germany Greece G… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1214-2023) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
epoc Host 2 as follows: Product SMN epoc Host 10736387 epoc Host 2, Canada 10736388 epoc Host 2, China 10736389 epoc Host 2, Japan 10736390 epoc Host 2, Refurbished 10736393 epoc Host 2, Canada, Refurbished 10736394 epoc Host 2, Japanese, Refurbished 10736395 epoc Host 2, Chinese, 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 - Refurbished 11413601 "epoc Host 2 (MC55X) - ROW -Refurbished" 11413602 epoc Host 2 (MC55X) - India - Refurbished 11413603 epoc Host 2 (MC55X) - Japan - Refurbished 11413604. Recalled by Siemens Healthcare Diagnostics Inc. Units affected: 22,156 units.
Why was this product recalled? ▼
pO2 High Recovery in Quality Control When Adjusted for Barometric Pressure
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 15, 2023. Severity: Moderate. Recall number: Z-1214-2023.
Where was the recalled product distributed? ▼
Distribution: Nationwide Foreign: Algeria Argentina Australia Austria Bahrain Belarus Belgium Bolivia Brazil Cambodia Canada Chile China Colombia Croatia Czech Republic Denmark Ecuador Egypt Estonia Finland France Fren.Polynesia Georgia Germany Greece Guadeloupe Hong Kong Hungary Iceland India Indonesia Iran Ireland Israel Italy Japan Jordan Kazakhstan Kenya Kuwait Laos Latvia Lithuania Luxembourg Malaysia Mali Martinique Mexico Myanmar Netherlands New Caledonia New Zealand Norway Papua Nw Guinea Peru Philippines Poland Portugal Qatar Republic Korea Reunion Romania Russian Fed. San Marino Singapore Slovakia Slovenia Solomon Islands South Africa Spain Sweden Switzerland Taiwan Thailand Tunisia Turkey U.A.E. Ukraine United Kingdom Uruguay Vietnam.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1214-2023) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported March 15, 2023. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.