Class II — Potential Health Hazard

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

TOSHIBA Kalare Diagnostic X-Ray System K110785 Recalled by Toshiba American Medical Systems Inc Due to Firm initiated recall because when radiographic conditions with...

Date: April 3, 2013
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

TOSHIBA Kalare Diagnostic X-Ray System K110785

Quantity: 153 units

Why Was This Recalled?

Firm initiated recall because when radiographic conditions with the small focus are set and the radiography ready switch is held down, the large focus is also heated after a few seconds or more. This occurs when the Automatic Exposure Function (AEC) function is used. As a result, a radiographic tube current exceeding the set value flows and a brighter image than expected is acquired.

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