Canon PET-CT Scanner Recalled for Software Malfunction Causing Scan Failures
Canon Medical System is recalling three Canon PET-CT Scanner units due to a software flaw that prevents automatic scan progression. This malfunction could cause diagnostic failures requiring unnecessary rescanning and contrast medium reinjection.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall describes a software malfunction causing potential diagnostic failure and unnecessary contrast reinjection. No illnesses or injuries are reported. Per the rubric, a risk-of-harm product without reported injury scores as High (3).
Plain-English summary
Canon Medical System, USA, INC. is recalling three Canon PET-CT Scanner units (Cartesion Prime, MODEL PCD-1000A) with serial numbers 3DA1982001, 3DA2072002, and 3DA2072003. The units were distributed nationwide in Nevada, Arkansas, and Minnesota.
A software problem has been identified that prevents the diagnostic imaging system from automatically proceeding to the next scan even when automatic start is specified. This malfunction could result in the system failing to complete the intended scan sequence, necessitating rescanning and reinjection of contrast medium.
Healthcare facilities that received these units should verify the serial number of their scanner against the recall list. Contact Canon Medical System, USA, INC. with questions or concerns regarding the affected units.
The recalled product
- Product
- Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A
- Manufacturer
- Canon Medical System, USA, INC.
- Affected units
- 3
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Affected serial numbers: 3DA1982001
- 3DA2072002
- 3DA2072003
Distribution
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