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U.S. Department of Health and Human Services

Class 2 Device Recall The Schiller PB 1000, also known as Merge Hemo Patient Data Module (PDM),

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  Class 2 Device Recall The Schiller PB 1000, also known as Merge Hemo Patient Data Module (PDM), see related information
Date Initiated by Firm March 10, 2016
Create Date July 10, 2017
Recall Status1 Terminated 3 on March 06, 2020
Recall Number Z-2707-2017
Recall Event ID 77086
510(K)Number K082421  
Product Classification Computer, diagnostic, programmable, cardiovascular - Product Code DQK
Product The Schiller PB 1000, also known as Merge Hemo Patient Data Module (PDM), a major component of the Merge Hemo software.
Code Information All Schiller PB-1000 PDM's distributed on or before 8/11/2016.
Recalling Firm/
Merge Healthcare, Inc.
900 Walnut Ridge Dr
Hartland WI 53029-8347
For Additional Information Contact Merge Service and Support
Manufacturer Reason
for Recall
If the PDM is utilized to output a pressure for computing fractional flow reserve (FFR), the analog output may not reflect the true representation of the selected pressure waveform being provided by the PDM to the Link Assembly which provides the analog output.
FDA Determined
Cause 2
Software design
Action The recalling firm issued recall letters dated 3/10/2016, 5/3/2016, and 8/5/2016 via email or via certified mail if the email address is not available.
Quantity in Commerce 555 PDM's
Distribution Distribution US nationwide.
Total Product Life Cycle TPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DQK and Original Applicant = EMAGEON INC.