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
|
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 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
|
|
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.
|