FDA Medical Device Recalls (openFDA)
Virtual Radiologic Corp.: vRad PACS with Mammography
- Recall number
- Z-2235-2023
- Recalling firm
- Virtual Radiologic Corp.
- Product
- vRad PACS with Mammography
- Status
- Open, Classified
- Initiated
- 2023-05-09
- Posted
- 2023-07-21
- Terminated
- not on file
- Reason
- The error resulted in intermittent failure of current (primary) radiology study images not displaying to the interpreting teleradiologist.
- Root cause
- Software Manufacturing/Software Deployment
- Action
- The firm issued an URGENT FIELD CORRECION notice to its consignees beginning on 06/28/2023 via email. The notice explained the issue, root cause, and repair of the software. It was recommended that those consignees who experienced the malfunction review the affected cases.
- Quantity
- 8 units
- Distribution
- US Nationwide distribution in the states of MD, MN, TN, FL, GA, TX, OK.
- Lot, serial or model codes
- (01)00862234000313(10)23.2 Build 23.2.0.117 through (01)00862234000313(10) 23.4 Build 23.4.25.1
- 510(k) numbers
- K162145
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 3007795813
- Firm city
- Eden Prairie
- Firm state
- MN
- 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