FDA Medical Device Recalls (openFDA)
Merge Healthcare, Inc.: iConnect Enterprise Archive. The firm name on the label is Merge Healthcare, Hartland, WI. iConnect Enterprise Archive is intended for use as a vendor neutral archive for storage and communications of medical images and data.
- Recall number
- Z-2686-2016
- Recalling firm
- Merge Healthcare, Inc.
- Product
- iConnect Enterprise Archive. The firm name on the label is Merge Healthcare, Hartland, WI. iConnect Enterprise Archive is intended for use as a vendor neutral archive for storage and communications of medical images and data.
- Status
- Terminated
- Initiated
- 2016-01-30
- Posted
- not on file
- Terminated
- 2019-10-15
- Reason
- Interventional Radiology (IR) images are stored as JPEG2k Lossless in Merge Enterprise Archive (EA) and are not displaying correctly in RadSuite.
- Root cause
- Software design
- Action
- The firm, Merge, sent an "URGENT: MEDICAL DEVICE RECALL" letters dated 1/29/2016 and 5/25/2016 via e-mail or via certified mail if they did not have an e-mail address for the customers. The letters described the product, problem and actions to be taken. The customers were instructed to do the following: you must discontinue using the affected version of RadSuite or iConnect Enterprise Archive with GE AW Workstation; use the workaround listed in the letter; complete and return the enclosed form no later than June 17, 2016; ensure that all users of the product are provided with the notification; if you have further distributed this product, please identify your customers and notify them at once of this product recall Merge has a released fix available for this issue. If you have any additional questions, please send an email to recall@merge.com or call 800-724-5970 ext 8027.
- Quantity
- 96 sites potentially have the affected versions for both products
- Distribution
- US Distribution to: CO and OK.
- Lot, serial or model codes
- Version: 8.80, 8.80.0.1, 8.80.0.2, 8.80.1.1, 8.80.2, and 8.80.2.1
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LMB
- 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