FDA Medical Device Recalls (openFDA)
Merge Healthcare, Inc.: iConnect Access software. The firm name on the label is Merge Healthcare, Hartland, WI.
- Recall number
- Z-0611-2017
- Recalling firm
- Merge Healthcare, Inc.
- Product
- iConnect Access software. The firm name on the label is Merge Healthcare, Hartland, WI.
- Status
- Terminated
- Initiated
- 2016-05-25
- Posted
- not on file
- Terminated
- 2019-08-28
- Reason
- Software displayed incorrect prior reports in the viewport area, only when more than one prior study (2 or more) was viewed.
- Root cause
- Software design
- Action
- The recalling firm issued a notification letter dated 1/27/2016 via email or via certified mail if the firm did not have an email address for the customer. Nonresponders were issued a second letter dated 5/25/2016 on 5/26/2016.
- Quantity
- 60 sites potentially have the affected versions
- Distribution
- Distribution was made to medical facilities nationwide. Foreign distribution was also made.
- Lot, serial or model codes
- Versions 3.0.1, 3.1, and 3.2
- 510(k) numbers
- K092915
- 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
- 2026-10-14
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