Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Merge Hemo

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Merge Hemosee related information
Date Initiated by FirmAugust 11, 2025
Date PostedSeptember 04, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2518-2025
Recall Event ID 97429
510(K)NumberK233326 
Product Classification Computer, diagnostic, programmable - Product Code DQK
ProductMerge 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.
Code Information Schiller Model Name: ARGUS PB-3000, Schiller Model #: 3.921002, Affected PB-3000 Serial Numbers: 7012.000035, 7012.000036, 7012.000037, 7012.000038, 7012.000041, 7012.000042, 7012.000044, 7012.000045, 7012.000046, 7012.000047, 7012.000048, 7012.000050, 7012.000051, 7012.000052, 7012.000053, 7012.000057, 7012.000058, 7012.000059, 7012.000060, 7012.000061, 7012.000062, 7012.000063, 7012.000064, 7012.000065, 7012.000066, 7012.000067, 7012.000068, 7012.000069, 7012.000071, 7012.000072, 7012.000073, 7012.000074, 7012.000075, 7012.000076, 7012.000078, 7012.000079, 7012.000080, 7012.000081, 7012.000082, 7012.000083, 7012.000085, 7012.000087, 7012.000088, 7012.000089, 7012.000090, 7012.000091, 7012.000092, 7012.000093, 7012.000094, 7012.000097, 7012.000098, 7012.000099, 7012.000100, 7012.000101, 7012.000102, 7012.000103, 7012.000104, 7012.000105, 7012.000106, 7012.000107, 7012.000108, 7012.000109, 7012.000110, 7012.000111, 7012.000112, 7012.000113, 7012.000114, 7012.000115, 7012.000116, 7012.000117, 7012.000118, 7012.000119, 7012.000120, 7012.000123, 7012.000124, 7012.000125, 7012.000126, 7012.000137, 7012.000138, 7012.000140, 7012.000141, 7012.000142, 7012.000157, 7012.000176
Recalling Firm/
Manufacturer		 Merge Healthcare, Inc.
900 Walnut Ridge Dr
Hartland WI 53029-8347
For Additional Information ContactNadia Marchant
+1-262-3670700
Manufacturer 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.
FDA Determined
Cause 2		Process control
ActionMerge Healthcare issued a Field Safety Corrective Action notice to its consignees on 08/12/2025 via email. The notice explained the issue with the device, potential risk to patients, and requested the following actions: Immediate actions to reduce risk to patients For customers using affected versions of Merge Hemo, the following action should be taken to mitigate the risk of non-invasive blood pressure (NIBP) becoming non-functional in the high-pressure range (>240 mmHg): " Ensure an alternative method for determining NIBP, such as a sphygmomanometer or other NIBP measuring device, is available during use of the Merge Hemo system. Actions being taken by Merge Merge Healthcare will contact you to arrange a no-charge inspection of your ARGUS PB-3000 device(s). If the device is affected by this issue, Merge Healthcare will provide a replacement ARGUS PB-3000 and send the affected device to Schiller AG. Please forward this notice to any individuals within your organization that may need to be aware of this notification. Customers should alert any other affiliated parties that may be affected by this Field Safety Corrective Action. Customers experiencing the reported issue should contact Merge Healthcare Support at 1-877-741-5369.
Quantity in Commerce84
DistributionUS 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = DQK
-
-