Date Initiated by Firm | July 23, 2021 |
Create Date | August 28, 2021 |
Recall Status1 |
Terminated 3 on August 29, 2023 |
Recall Number | Z-2387-2021 |
Recall Event ID |
88379 |
510(K)Number | K152864 |
Product Classification |
Computer, diagnostic, programmable - Product Code DQK
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Product | Merge Hemo, Software packages 10.2, 10.3, and 10.4 |
Code Information |
Version 10.2, UDI (01)00842000100430(10)10.2(11)190612 Version 10.3, UDI (01)00842000100874(10)10.3(11)200330 Version 10.4, UDI (01)00842000100966(10)10.4(11)210428 |
Recalling Firm/ Manufacturer |
Merge Healthcare, Inc. 900 Walnut Ridge Dr Hartland WI 53029-8347
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For Additional Information Contact | Mr. Todd Brill 627-528-1732 |
Manufacturer Reason for Recall | The firm identified a safety issue affecting the software associated with Merge Hemo versions 9.x and 10.x, used in combination with an HL7 lab interface. |
FDA Determined Cause 2 | Under Investigation by firm |
Action | The firm issued an Urgent Field Safety Notice by email on 07/23/2021. The letter explained the issue and provided a workaround for the safe, continued use of the instrument until a software correction can be made. |
Quantity in Commerce | 326 units |
Distribution | US 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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