—#146916

Product

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.

FDA product code: KPS — System, Tomography, Computed, Emission
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K123737
Affected lot / code info: Serial Number 11022

Why it was 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.

Root cause (FDA determination)

Process design

Action the firm took

Siemens sent a Customer Safety Advisory Letter to all affected customers. The letter identified the affected product, problem and actions to be taken. Siemens service organization will be contacting customers to schedule the update as per the attached Update Instruction and will be provided the replacement bracket to resolve the issue. For questions contact your Siemens representative.

Recalling firm

Firm: Siemens Medical Solutions USA Inc.
Address: 810 Innovation Dr, Knoxville, Tennessee 37932-2562

Distribution

Distribution pattern: Worldwide Distribution - US Nationwide and the countries of China and Malaysia.

Timeline

Recall initiated: 2016-04-25
Posted by FDA: 2016-06-15
Terminated: 2017-02-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #146916. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.