Toshiba CT Systems Recalled for Potential Table Position Errors
Toshiba American Medical Systems is recalling 757 CT systems because a table control board defect may cause patients to be scanned at incorrect positions.
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: The recall involves a risk-of-harm product where injury has not yet been reported, as the defect may lead to patients being scanned at incorrect positions.
Plain-English summary
Toshiba American Medical Systems Inc is recalling 757 Toshiba CT systems, including Asteion and Aquilion models, that are equipped with a PC-based computer or older SGI-based systems that received an improved table upgrade. The recall is due to a defect in the table control board.
The defective board may cause the table position to be incorrect if the table cradle is moved manually, a function referred to as "Free" mode in the operation manuals. If this error occurs, it is possible that a patient could be scanned at an incorrect position.
The affected units were distributed nationwide in the USA. Healthcare facilities should contact Toshiba American Medical Systems Inc to arrange for the necessary corrective actions.
The recalled product
- Product
- Toshiba CT systems, Asteion and Aquilion, that are equipped with a PC based computer, or to those older systems (SGI based) that received an improved table by an upgrade purchase. This device is designed to produce cross-sectional images of a human body by reconstruction of…
- Manufacturer
- Toshiba American Medical Systems Inc
- Category
- Medical Device — CT Scanner
- Hazard
- Affected units
- 757
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 (10)
- Serial Number Range (last 4): (2665-3149)
- (2211-2237)
- (2057-2067)
- A3622041
- A4582122 + (2690-3131)
- (2001-2171)
- (2001-2124)
- (2001-2255)
- (2001-3007)
- (2015-2061)
Distribution
Distributed nationwide across the United States.
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