Class 2 Device Recall The Schiller PB 1000

• Date Initiated by Firm: May 31, 2015
• Create Date: February 15, 2017
• Recall Status: Terminated 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
• 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
• 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: 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

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.