FDA Medical Device Recalls (openFDA)
Cuattro LLC: CuattroDR System Software, REF: SWR-00069-MD, UDI: B269SWR00069MD0
- Recall number
- Z-1934-2020
- Recalling firm
- Cuattro LLC
- Product
- CuattroDR System Software, REF: SWR-00069-MD, UDI: B269SWR00069MD0
- Status
- Terminated
- Initiated
- 2019-10-15
- Posted
- not on file
- Terminated
- 2021-04-27
- Reason
- There is a potential that an image from a previous patient study to show up in a later patient study. This may result in misdiagnosis of the correct patient.
- Root cause
- Device Design
- Action
- On October 15, 2019, The firm contacted all affected consignees via phone call. In addition to informing consignees about the recall. The firm provided the following information to consignees: . To prevent a reoccurrence of this problem Cuattro has updated the settings file in the program data folder on your acquisition workstation. This update to the file will prevent any backup images from being downloaded to the acquisition workstation. This was completed for your system on September 6, 2019, service ticket number 70002871
- Quantity
- 9 units
- Distribution
- US: NJ, MI, SC, NC, MI, AR, OUS: None
- Lot, serial or model codes
- Product Version: 4.4.128
- 510(k) numbers
- ["K161937"]
- PMA numbers
- not on file
- Product code
- KPR
- Firm FEI
- 3008364043
- Firm city
- Golden
- Firm state
- CO
- 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