Date Initiated by Firm | May 31, 2015 |
Create Date | February 15, 2017 |
Recall Status1 |
Terminated 3 on March 13, 2020 |
Recall Number | Z-1203-2017 |
Recall Event ID |
75616 |
510(K)Number | K082421 |
Product Classification |
Computer, diagnostic, programmable - Product Code DQK
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Product | The Schiller PB 1000, also known as: Merge Hemo Patient Data Module (PDM), V2 model, a major component of the Merge Hemo software. |
Code Information |
Patient Data Module (PDM) V2 model: Serial numbers 10.03.XXXXX |
Recalling Firm/ Manufacturer |
Merge Healthcare, Inc. 900 Walnut Ridge Dr Hartland WI 53029-8347
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For Additional Information Contact | Merge Service and Support 877-741-5369 |
Manufacturer Reason for Recall | Non-invasive blood pressure pumps (NIBP) voltage is not sufficient and causes the NIBP pumps to fail prior to reaching adequate initial pressure. |
FDA Determined Cause 2 | Nonconforming Material/Component |
Action | The recalling firm issued letters via email dated 3/28/2016 and 7/11/2016, or via certified mail if no email address was available. A third letter dated 1/23/2017 was also issued.. |
Quantity in Commerce | 341 sites potentially have the affected product versions |
Distribution | Distribution was nationwide to medical facilities. There was also military and government distribution. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = DQK
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