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 Recall Z-2000-2016 · Posted 2016-06-15
Advertisement
Recalling FirmSiemens Medical Solutions USA Inc.
Recall StatusTerminated
Product CodeKPS
Date Initiated2016-04-25
Date Terminated2017-02-01
Product Quantity1 unit
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.
Firm Action
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.
Root Cause
Process design
Distribution Pattern
Worldwide Distribution - US Nationwide and the countries of China and Malaysia.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement