FDA Medical Device Recalls (openFDA)
Merge Healthcare, Inc.: Merge PACS software. 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.
- Recall number
- Z-0726-2017
- Recalling firm
- Merge Healthcare, Inc.
- Product
- Merge PACS software. 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.
- Status
- Terminated
- Initiated
- 2016-03-28
- Posted
- not on file
- Terminated
- 2021-05-07
- Reason
- Cut lines on the image may present horizontally rather than vertically.
- Root cause
- Component design/selection
- Action
- MERGE sent an Urgent Medical Device Recall dated March 28, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Merge Healthcare is working on correcting the issues and will inform customers once a fix is made available. Customers were asked to reply using the enclosed form and the return addressed envelope. If customers have further distributed the affected product they need to identify their customers and notify them at once of the product recall. Customers with questions were instructed to send an email to recall@merge.com.
- Quantity
- 537 sites potentially have the affected versions
- Distribution
- Worldwide Distribution - US (nationwide) Canada and foreign distribution
- Lot, serial or model codes
- Versions V6 GA, 6.0 MR1, V6 MR1 CU1,V6 MR1 CU1 SF1, V6 MR1 CU4, V6 MR1 CU5, V6 MR1 CU6, V6 MR1 CU7,V6 MR1 CU8, 6.0 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
- 510(k) numbers
- ["K082144"]
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 1000116130
- Firm city
- Hartland
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28