Toshiba Infinix X-Ray System Recalled for Table Movement Safety Issue
Toshiba is recalling two Infinix X-Ray Interventional Systems because the table may continue moving during longitudinal tilt despite error signals.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a mechanical defect that allows a heavy table to continue moving despite safety signals, posing a significant risk of injury.
Plain-English summary
Toshiba American Medical Systems Inc is recalling two units of the Toshiba Infinix X-Ray Interventional System (INFX-8000V/UU). This medical device is an X-Ray system used for radiographic and fluoroscopic studies in an interventional setting.
The recall is due to a safety issue where the table's longitudinal tilt movement does not stop when the Flat Panel Detector (FPD) touch sensor is activated. Although an error message is displayed and an audible signal sounds, the table continues to move, which poses a risk of injury to patients or staff.
The affected units were distributed nationwide, including in California and Indiana. The specific serial numbers for the recalled units are ULD1412014, UUC13Z2011, and A4A113Z2001. Healthcare facilities should contact Toshiba American Medical Systems Inc to arrange for the necessary corrective actions.
The recalled product
- Product
- Toshiba Infinix X-Ray Interventional System INFX-8000V/UU. An X-Ray system that is capable of radiographic and fluoroscopic studies used in an interventional setting.
- Manufacturer
- Toshiba American Medical Systems Inc
- Affected units
- 2
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)
- Serial Numbers: ULD1412014
- UUC13Z2011
- A4A113Z2001.
Distribution
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