Canon Medical System, USA, INC. Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A
Brand
Canon Medical System, USA, INC.
Lot Codes / Batch Numbers
Affected serial numbers: 3DA1982001, 3DA2072002, 3DA2072003
Products Sold
Affected serial numbers: 3DA1982001, 3DA2072002, 3DA2072003
Canon Medical System, USA, INC. is recalling Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A due to A software problem has been identified which could result in the diagnostic imaging system not proceeding to the next actual scan even though automat. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026