Class II — Potential Health Hazard

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

Philips Multi Diagnost Eleva with FlatDetector Recalled by Philips Medical Systems, Inc. Due to The possibility of the Reference Air Kerma Rate...

Date: October 14, 2013
Company: Philips 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 Philips Medical Systems, Inc. directly.

Affected Products

Philips Multi Diagnost Eleva with FlatDetector

Quantity: 238

Why Was This Recalled?

The possibility of the Reference Air Kerma Rate for low dose mode will not be reduced to 50% of the value for the normal mode, but will be approximately 70-80%, leading to a higher patient dose than expected.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Philips Medical Systems, Inc.

Philips Medical Systems, Inc. has 65 total recalls tracked by RecallDetector.

Related Recalls

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