Class II — Potential Health Hazard

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

Biograph mCT: a) S(64)-3R Recalled by Siemens Medical Solutions USA, Inc. Due to The terminals on the plug may become loose...

Date: September 28, 2018
Company: Siemens Medical Solutions USA, 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 Siemens Medical Solutions USA, Inc. directly.

Affected Products

Biograph mCT: a) S(64)-3R, Material Number 10248669 b) S (20) -3R, Material Number 10507786 c) Flow 20-4R, Material Number 10528958 d) m Flow 64-4R, Material Number 10529161 e) mCT S(40)-4R, Material Number 10248671 f) mCT S(64)-4R, Material Number 0248672 g) mCT S(20)-3R, Material Number 10534159 h) mCT Flow Edge-4R, Material Number 10528955 i) mCT Flow 40-3R, Material Number 10529158 j) mCT Flow 64-3R, Material Number 10529160 k) mCT X-4R, Material Number 10248670 l) mCT X-3R, Material Number 10248673 m) mCT S(20)-4R, Material Number 10534160 n) mCT S(40)-3R, Material Number 10248668 o) mCT Flow 40-4R, Material Number 10529159 p) mCT Flow 20-3R, Material Number 10528956 q) mCT Flow Edge-3R, Material Number 10528954 The Siemens Biograph Horizon and Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.

Quantity: 890 units

Why Was This Recalled?

The terminals on the plug may become loose and overheat.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Siemens Medical Solutions USA, Inc.

Siemens Medical Solutions USA, Inc. has 87 total recalls tracked by RecallDetector.

Related Recalls

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