| Class 2 Device Recall Merge PACS software. | |
Date Initiated by Firm | March 28, 2016 |
Create Date | November 17, 2016 |
Recall Status1 |
Terminated 3 on April 23, 2021 |
Recall Number | Z-0599-2017 |
Recall Event ID |
75629 |
510(K)Number | K082144 |
Product Classification |
System, image processing, radiological - Product Code LLZ
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Product | Merge PACS software.
Product Usage:
Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication and storage of studies produced by digital modalities, including digital mammography. |
Code Information |
Versions: V6.0 MR2, 6.0 MR3, 6.0 MR3 CU, 6.0 MR4, 6.0 MR4 CU1, 6.0 MR4 CU2, 6.0 MR4 CU3, 6.0 MR4 CU4, 6.0 MR4 CU5, 6.0 MR4 CU6, 6.0 MR4, CU7, 6.0 MR4 CU8, 6.0 MR4 CU9, 6.0 MR4 CU10, 6.0 MR4 CU11, 6.1, 6.1.1, 6.1.2, 6.1.3, 6.2, 6.2.1, 6.2.2, 6.2.3, 6.2.4, 6.2.5, 6.3, 6.4, 6.4.1, 6.4.2, 6.4.3, 6.4.4, 6.4.5, 6.4.6, 6.4.7, 6.5, 6.5.5, 6.5.6, 6.5.7, 6.5.8, 6.5.9, 6.6, 6.6.1, 6.6.1.1, 6.6.2, 6.6.2.1, 6.6.2.2, 7.0, 7.0.1, and 7.0.2. |
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 | The software did not show unviewed images when the last view was skipped. The physician may potentially misdiagnose when not all images are available for viewing. |
FDA Determined Cause 2 | Software design |
Action | The recalling firm issued a letter dated March 28, 2016 via e-mail or via certified mail to customers. The letter identified the affected product, problem and actions to be taken. The notification instructs the customer to pass the information onto all other users, as well as any downstream customers if it was further distributed. The notification also informs the customer their response is required using the enclosed form and the return addressed envelope. |
Quantity in Commerce | 534 sites potentially have the affected versions |
Distribution | Worldwide Distribution - US Nationwide including Canada. |
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 = LLZ
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