FDA Medical Device Recalls (openFDA)
Adac Labs: Emission Computed Tomography System
- Recall number
- Z-1079-04
- Recalling firm
- Adac Labs
- Product
- Emission Computed Tomography System
- Status
- Terminated
- Initiated
- 2004-06-21
- Posted
- 2004-07-20
- Terminated
- 2005-12-19
- Reason
- Software problems may cause the detector head to drift unexpectedly
- Root cause
- Other
- Action
- Notification letter sent to consignees 6/21/2004, software update pending (mandatory upgrade)
- Quantity
- 482 units
- Distribution
- Nationwide, all direct accounts
- Lot, serial or model codes
- model number 2163-3000A, 2163-3000B
- 510(k) numbers
- ["K011611"]
- PMA numbers
- not on file
- Product code
- KPS
- Firm FEI
- 1525965
- Firm city
- Milpitas
- Firm state
- CA
- 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