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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 FirmMarch 10, 2016
Create DateJuly 10, 2017
Recall Status1 Terminated 3 on March 06, 2020
Recall NumberZ-2707-2017
Recall Event ID 77086
510(K)NumberK082421 
Product Classification Computer, diagnostic, programmable, cardiovascular - Product Code DQK
ProductThe 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/
Manufacturer		 Merge Healthcare, Inc.
900 Walnut Ridge Dr
Hartland WI 53029-8347
For Additional Information ContactMerge Service and Support
877-741-5369
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
ActionThe 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 Commerce555 PDM's
DistributionDistribution US nationwide.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = DQK
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