Recall archive
7 recalls · page 1 of 1
Reported Mar 15, 2017
Biograph 6 TruePoint, Material Number 10097289 The Biograph Mobile PET/CTs are intended to be utilized by appropriately…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA Inc.
Matched: Brand — The mobile-specific instructions was not shipped to a limited population of Biograph Mobile systems.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 18, 2017
Biograph mCT S(40)-3R, Material Number 10248668 The Siemens Biograph mCT and Biograph mCT Flow systems are combined…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA Inc.
Matched: Brand · Product · Product details · Reason for recall — Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off.
10 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 29, 2016
Biograph mCT-X 4R, MATERIAL NUMBER 10248670 The Siemens Biograph TruePoint systems are combined X-Ray Computed…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA Inc.
Matched: Brand · Product · Product details · Reason for recall — Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for…
32 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 22, 2016
BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10507786 Product Usage: The Siemens Biograph mCT systems are combined X-Ray…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA Inc.
Matched: Brand · Product · Product details — 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.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 12, 2015
Biograph mCT S(40)-4R, Model Number 10248671
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA Inc.
Matched: Brand — Emission computed tomography systems and computed tomography xray systems with optional ceiling mounts may be missing a locking ring.
7 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 24, 2014
Biograph mCT Flow Edge-4R, System Material Number 10528955. The Siemens Biograph mCT systems are combined X-Ray…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA Inc.
Matched: Brand · Product · Product details — Possibility for system display freeze during CT interventional procedures.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 20, 2013
ACUSON S2000 Automated Breast Volume Scanner (ABVS); Model number 10042541 Distributed by Siemens Medical Solutions USA…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
Matched: Brand · Product · Product details — On some ACUSON S2000 ABVS systems, the inside of the transducer pod may contain sharp edges.
FDA (openFDA device enforcement)
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