Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported September 10, 2025
Merge Hemo, Model RCSV2, Model/Catalog Number 99-01172-00, software versions 11.1 and 11.1.1 Product Description: The Merge Hemo, Model RCSV2 device is a hemodynamics recording computer system that monitors, measures, displays, records and stores various physiologic and blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices. The system is used for documenting and monitoring patients undergoing diagnostic and interventional catheter-based procedu
Merge Healthcare has been informed by Schiller AG (Baar, Switzerland) of an issue with the Schiller ARGUS PB-3000 Patient Data Module (PDM) where certain units trigger an error me…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Merge Healthcare, Inc. recalled Merge Hemo, Model RCSV2, Model/Catalog Number 99-01172-00, software versions 11.1 and 11.… - a moderate-severity action.
Merge Hemo, Model RCSV2, Model/Catalog Number 99-01172-00, software versions 11.1 and 11.… was recalled by Merge Healthcare, Inc. in September 10, 2025. Reason: Merge Healthcare has been informed by Schiller AG (Baar, Switzerland) of an issue with the Schiller ARGUS PB-…. Check the official notice for the remedy. Verify recall #Z-2518-2025 with the FDA Devices before acting.
The recall
Merge Healthcare, Inc. issued this moderate-severity FDA Devices recall-Merge Healthcare has been informed by Schiller AG (Baar, Switzerland) of an issue with the Schiller ARGUS PB-….
- Moderate
- severity level
- 84 units
- affected scope
- Class II
- classification
- September 10, 2025
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2518-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2518-2025) was formally reported on September 10, 2025, with the manufacturer initiating the action on August 11, 2025. It is classified under Moderate severity (Class II), with a current status of Ongoing. Merge Healthcare, Inc. is listed as the recalling firm, operating out of Hartland, WI. Federal records list the affected scope as 84.
The documented reason for this recall is: Merge Healthcare has been informed by Schiller AG (Baar, Switzerland) of an issue with the Schiller ARGUS PB-3000 Patient Data Module (PDM) where certain units trigger an error message on the Merge Hemo Client ( Pressur… Distribution data in the federal record shows the product reached: US Nationwide distribution including in the states of Arizona, Arkansas, California, Florida, Louisiana, Mississippi, North Carolina, North Dakota, Oklahoma, Pennsylvania, Georgia, Illinois, Kentucky, Tennessee, Texas, …. 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
84
Related Recalls
6
3 from same agency
Product description
Merge Hemo, Model RCSV2, Model/Catalog Number 99-01172-00, software versions 11.1 and 11.1.1 Product Description: The Merge Hemo, Model RCSV2 device is a hemodynamics recording computer system that monitors, measures, displays, records and stores various physiologic and blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices. The system is used for documenting and monitoring patients undergoing diagnostic and interventional catheter-based procedures. The procedures can be performed in the clinical areas of invasive cardiology, interventional radiology, and cardiac electrophysiology.
Reason for recall
Merge Healthcare has been informed by Schiller AG (Baar, Switzerland) of an issue with the Schiller ARGUS PB-3000 Patient Data Module (PDM) where certain units trigger an error message on the Merge Hemo Client ( Pressure Sensor Defective ) during non-invasive blood pressure (NIBP) measurements, specifically when the initial inflation pressure is set in the high-pressure range (>240 mmHg). The ARGUS PB-3000 is a vital signs monitoring instrument intended to be integrated into the Merge Hemo System. No other components of the Merge Hemo System are affected.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-2518-2025 |
| Date reported | September 10, 2025 |
| Date initiated | August 11, 2025 |
| Recalling firm | Merge Healthcare, Inc. |
| Firm location | Hartland, WI |
| Affected scope | 84 |
| Distribution | US Nationwide distribution including in the states of Arizona, Arkansas, California, Florida, Louisiana, Mississippi, North Carolina, North Dakota, Oklahoma, Pennsylvania, Georgia, Illinois, Kentucky, Tennessee, Texas, Washington, and Wisc… |
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-2518-2025) 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? ▼
Merge Hemo, Model RCSV2, Model/Catalog Number 99-01172-00, software versions 11.1 and 11.1.1 Product Description: The Merge Hemo, Model RCSV2 device is a hemodynamics recording computer system that monitors, measures, displays, records and stores various physiologic and blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices. The system is used for documenting and monitoring patients undergoing diagnostic and interventional catheter-based procedures. The procedures can be performed in the clinical areas of invasive cardiology, interventional radiology, and cardiac electrophysiology.. Recalled by Merge Healthcare, Inc.. Units affected: 84.
Why was this product recalled? ▼
Merge Healthcare has been informed by Schiller AG (Baar, Switzerland) of an issue with the Schiller ARGUS PB-3000 Patient Data Module (PDM) where certain units trigger an error message on the Merge Hemo Client ( Pressure Sensor Defective ) during non-invasive blood pressure (NIBP) measurements, specifically when the initial inflation pressure is set in the high-pressure range (>240 mmHg). The ARGUS PB-3000 is a vital signs monitoring instrument intended to be integrated into the Merge Hemo System. No other components of the Merge Hemo System are affected.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 10, 2025. Severity: Moderate. Recall number: Z-2518-2025.
Where was the recalled product distributed? ▼
Distribution: US Nationwide distribution including in the states of Arizona, Arkansas, California, Florida, Louisiana, Mississippi, North Carolina, North Dakota, Oklahoma, Pennsylvania, Georgia, Illinois, Kentucky, Tennessee, Texas, Washington, and Wisconsin..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2518-2025) 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 September 10, 2025. 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.