FDA Medical Device Recalls (openFDA)
Canon Medical System, USA, INC.: Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A
- Recall number
- Z-0142-2022
- Recalling firm
- Canon Medical System, USA, INC.
- Product
- Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A
- Status
- Terminated
- Initiated
- 2020-11-11
- Posted
- not on file
- Terminated
- 2023-06-30
- Reason
- A software problem has been identified which could result in the diagnostic imaging system not proceeding to the next actual scan even though automatic start of the next scan is specified. This could result in the diagnostic imaging system failing resulting in rescanning and reinjection of contrast medium.
- Root cause
- Software design
- Action
- On November 11, 2020, Canon Medical Systems visited affected consignees and updated affected software. After completion of the software update, the consignee was provided a "Recall field Modification Instruction" document concerning the correction.
- Quantity
- 3 units
- Distribution
- US Nationwide distribution in the states of NV, AR MN.
- Lot, serial or model codes
- Affected serial numbers: 3DA1982001, 3DA2072002, 3DA2072003
- 510(k) numbers
- ["K203314"]
- PMA numbers
- not on file
- Product code
- KPS
- Firm FEI
- 2020563
- Firm city
- Tustin
- 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