Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Aquilion Prime TSX-303A Aquilion PRIME is a multislice helical CT Recalled by Toshiba American Medical Systems Inc Due to Toshiba American Medical Systems (TAMS) is recalling the...

Date: October 25, 2016
Company: Toshiba American Medical Systems Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Toshiba American Medical Systems Inc directly.

Affected Products

Aquilion Prime TSX-303A Aquilion PRIME is a multislice helical CT system with an 40-row detector. High-speed rotation allows rapid data acquisition and shortens scan times, while the fast reconstruction unit further improves throughput, reducing the time required for diagnosis.

Quantity: 291 units

Why Was This Recalled?

Toshiba American Medical Systems (TAMS) is recalling the Aquilion CT system because it has been reported that the cooling oil in the x-ray tube heat exchanger may leak during system operation.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Toshiba American Medical Systems Inc

Toshiba American Medical Systems Inc has 56 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report