PlainRecalls
FDA Devices Moderate Class II Terminated

BIOGRAPH mCT S(20) - 4R, MATERIAL NUMBER 10528958 Product Usage: The Siemens 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.

Reported: June 22, 2016 Initiated: April 25, 2016 #Z-2000-2016

Product Description

BIOGRAPH mCT S(20) - 4R, MATERIAL NUMBER 10528958 Product Usage: The Siemens 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.

Reason for Recall

The bracket that is used to lift the cover has bolts that were not welded in potentially causing the cover to fall down during service.

Details

Units Affected
1 unit
Distribution
Worldwide Distribution - US Nationwide and the countries of China and Malaysia.
Location
Knoxville, TN

Frequently Asked Questions

What product was recalled?
BIOGRAPH mCT S(20) - 4R, MATERIAL NUMBER 10528958 Product Usage: The Siemens 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.. Recalled by Siemens Medical Solutions USA Inc.. Units affected: 1 unit.
Why was this product recalled?
The bracket that is used to lift the cover has bolts that were not welded in potentially causing the cover to fall down during service.
Which agency issued this recall?
This recall was issued by the FDA Devices on June 22, 2016. Severity: Moderate. Recall number: Z-2000-2016.