Siemens Medical Solutions USA Inc.

Complete recall history across all FDA and CPSC categories, 65 total recalls

Siemens Medical Solutions USA Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (65)

FDA medical device enforcement actions by Siemens Medical Solutions USA Inc.. Showing most recent 50.

Date Product Reason Class
Feb 20, 2017 Biograph 6 TruePoint, Material Number 10097290 The Biograph Mobile PET/CTs... The mobile-specific instructions was not shipped to a limited population of B... Class II
Feb 20, 2017 Biograph 16 TruePoint TrueV - 4R, Material Number 10249556 The Biograph Mo... The mobile-specific instructions was not shipped to a limited population of B... Class II
Feb 20, 2017 Biograph 6 TruePoint, Material Number 10097289 The Biograph Mobile PET/CTs... The mobile-specific instructions was not shipped to a limited population of B... Class II
Feb 20, 2017 Biograph 16 TruePoint - 3R, Material Number 10249555 The Biograph Mobile P... The mobile-specific instructions was not shipped to a limited population of B... Class II
Dec 13, 2016 Biograph mCT X-4R, Material Number 10248670 The Siemens Biograph mCT and Bi... Siemens Medical Solutions, Molecular Imaging has become aware, through our su... Class II
Dec 13, 2016 Biograph mCT Flow Edge-4R, Material Number 10528955 The Siemens Biograph mC... Siemens Medical Solutions, Molecular Imaging has become aware, through our su... Class II
Dec 13, 2016 Biograph mCT S(40)-3R, Material Number 10248668 The Siemens Biograph mCT an... Siemens Medical Solutions, Molecular Imaging has become aware, through our su... Class II
Dec 13, 2016 Biograph mCT Flow 40-4R, Material Number 10529159 The Siemens Biograph mCT ... Siemens Medical Solutions, Molecular Imaging has become aware, through our su... Class II
Dec 13, 2016 BIOGRAPH mCT 20 Excel, Material Number 10507786 The Siemens Biograph mCT an... Siemens Medical Solutions, Molecular Imaging has become aware, through our su... Class II
Dec 13, 2016 Biograph mCT X-3R, Material Number 10248673 The Siemens Biograph mCT and Bi... Siemens Medical Solutions, Molecular Imaging has become aware, through our su... Class II
Dec 13, 2016 Biograph mCT S(64)-3R, Material Number 10248669 The Siemens Biograph mCT an... Siemens Medical Solutions, Molecular Imaging has become aware, through our su... Class II
Dec 13, 2016 Biograph mCT S(64)-4R, Material Number 10248672 The Siemens Biograph mCT an... Siemens Medical Solutions, Molecular Imaging has become aware, through our su... Class II
Dec 13, 2016 Biograph mCT S(40)-4R, Material Number 10248671 The Siemens Biograph mCT an... Siemens Medical Solutions, Molecular Imaging has become aware, through our su... Class II
Dec 13, 2016 Biograph mCT-X w/TrueV Upgrade, Material Number 10250745 The Siemens Biogra... Siemens Medical Solutions, Molecular Imaging has become aware, through our su... Class II
Dec 13, 2016 Bio mCT-S(40) 3R->4R Upgrade, Material Number 10250743 The Siemens Biograph... Siemens Medical Solutions, Molecular Imaging has become aware, through our su... Class II
Apr 25, 2016 BIOGRAPH mCT S(20) - 4R, MATERIAL NUMBER 10528958 Product Usage: The Siem... The bracket that is used to lift the cover has bolts that were not welded in ... Class II
Apr 25, 2016 BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10507786 Product Usage: The Siem... The bracket that is used to lift the cover has bolts that were not welded in ... Class II
Apr 25, 2016 BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10528956 Product Usage: The Siem... The bracket that is used to lift the cover has bolts that were not welded in ... Class II
Apr 25, 2016 Biograph mCT-S(64) 4R, MATERIAL NUMBER 10248672 Product Usage: The Siemen... The bracket that is used to lift the cover has bolts that were not welded in ... Class II
Apr 22, 2016 BIOGRAPH 40 TruePoint, Material Number 10097303 The Siemens Biograph TruePo... Siemens Medical Solutions, Molecular Imaging has become aware of a potential ... Class II
Apr 22, 2016 BIOGRAPH 40 - 3 Ring, Material Number 10097233 The Siemens Biograph TruePoin... Siemens Medical Solutions, Molecular Imaging has become aware of a potential ... Class II
Apr 22, 2016 Biograph 16 TruePoint TV, Material Number 10249556 The Siemens Biograph True... Siemens Medical Solutions, Molecular Imaging has become aware of a potential ... Class II
Apr 22, 2016 BIOGRAPH mCT Flow Edge-3R, MATERIAL NUMBER 10528954 The Siemens Biograph T... Siemens Medical Solutions, Molecular Imaging has become aware of a potential ... Class II
Apr 22, 2016 BIOGRAPH mCT Flow 40-4R, MATERIAL NUMBER 10529159 The Siemens Biograph Tru... Siemens Medical Solutions, Molecular Imaging has become aware of a potential ... Class II
Apr 22, 2016 BIOGRAPH mCT Flow 20-3R, MATERIAL NUMBER 10528956 The Siemens Biograph Tru... Siemens Medical Solutions, Molecular Imaging has become aware of a potential ... Class II
Apr 22, 2016 BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10507786 The Siemens Biograph Tru... Siemens Medical Solutions, Molecular Imaging has become aware of a potential ... Class II
Apr 22, 2016 BIOGRAPH mCT Flow Edge-4R, MATERIAL NUMBER 10528955 The Siemens Biograph T... Siemens Medical Solutions, Molecular Imaging has become aware of a potential ... Class II
Apr 22, 2016 BIOGRAPH 6 TruePoint, Material Number 10097289 The Siemens Biograph TruePo... Siemens Medical Solutions, Molecular Imaging has become aware of a potential ... Class II
Apr 22, 2016 Biograph mCT-X 3R, MATERIAL NUMBER 10248673 The Siemens Biograph TruePoint... Siemens Medical Solutions, Molecular Imaging has become aware of a potential ... Class II
Apr 22, 2016 Biograph mCT-S(40) 3R, MATERIAL NUMBER 10248668 The Siemens Biograph TrueP... Siemens Medical Solutions, Molecular Imaging has become aware of a potential ... Class II
Apr 22, 2016 Biograph mCT-S(64) 4R, MATERIAL NUMBER 10248672 The Siemens Biograph TrueP... Siemens Medical Solutions, Molecular Imaging has become aware of a potential ... Class II
Apr 22, 2016 BIOGRAPH SYS 64-3R to 64-4R, MATERIAL NUMBER 10246389 The Siemens Biograph T... Siemens Medical Solutions, Molecular Imaging has become aware of a potential ... Class II
Apr 22, 2016 BIOGRAPH 64 - 3 Ring, Material Number 08727450 The Siemens Biograph TruePo... Siemens Medical Solutions, Molecular Imaging has become aware of a potential ... Class II
Apr 22, 2016 Biograph mCT-S(40) 4R, MATERIAL NUMBER 10248671 The Siemens Biograph TrueP... Siemens Medical Solutions, Molecular Imaging has become aware of a potential ... Class II
Apr 22, 2016 BIOGRAPH 64-4R TruePoint w/TrueV, MATERIAL NUMBER 10097302 The Siemens Bio... Siemens Medical Solutions, Molecular Imaging has become aware of a potential ... Class II
Apr 22, 2016 Biograph Sys 16-3R to 16-4R upgrade, MATERIAL NUMBER 10525581 The Siemens ... Siemens Medical Solutions, Molecular Imaging has become aware of a potential ... Class II
Apr 22, 2016 Biograph 6 TP 3R to 4R Upgrade, Material Number 10246387 The Siemens Biogr... Siemens Medical Solutions, Molecular Imaging has become aware of a potential ... Class II
Apr 22, 2016 Biograph mCT-X 4R, MATERIAL NUMBER 10248670 The Siemens Biograph TruePoint... Siemens Medical Solutions, Molecular Imaging has become aware of a potential ... Class II
Apr 22, 2016 SYS IVK, Bio mCT-X 3R->4R Upgrade, MATERIAL NUMBER 10250745 The Siemens Bi... Siemens Medical Solutions, Molecular Imaging has become aware of a potential ... Class II
Apr 22, 2016 Biograph 16 TruePoint, MATERIAL NUMBER 10249555 The Siemens Biograph TrueP... Siemens Medical Solutions, Molecular Imaging has become aware of a potential ... Class II
Apr 22, 2016 BIOGRAPH 64-3R TruePoint, MATERIAL NUMBER 10097301 The Siemens Biograph Tr... Siemens Medical Solutions, Molecular Imaging has become aware of a potential ... Class II
Apr 22, 2016 BIOGRAPH Sys 40-3R to 40-4R, MATERIAL NUMBER 10246388 The Siemens Biograph... Siemens Medical Solutions, Molecular Imaging has become aware of a potential ... Class II
Apr 22, 2016 BIOGRAPH mCT Flow 64-3R, MATERIAL NUMBER 10529160 The Siemens Biograph Tru... Siemens Medical Solutions, Molecular Imaging has become aware of a potential ... Class II
Apr 22, 2016 BIOGRAPH mCT S(20)-4R, MATERIAL NUMBER 10534160 The Siemens Biograph TrueP... Siemens Medical Solutions, Molecular Imaging has become aware of a potential ... Class II
Apr 22, 2016 BIOGRAPH 6-4R TruePoint w/TrueV, MATERIAL NUMBER 10097290 The Siemens Biog... Siemens Medical Solutions, Molecular Imaging has become aware of a potential ... Class II
Apr 22, 2016 BIOGRAPH 40-3R to 64-3R Upgrade, Material Number 10246390 The Siemens Biog... Siemens Medical Solutions, Molecular Imaging has become aware of a potential ... Class II
Apr 22, 2016 BIOGRAPH mCT Flow 40-3R, MATERIAL NUMBER 10529158 The Siemens Biograph Tru... Siemens Medical Solutions, Molecular Imaging has become aware of a potential ... Class II
Apr 22, 2016 BIOGRAPH mCT Flow 64-4R, MATERIAL NUMBER 10529161 The Siemens Biograph Tru... Siemens Medical Solutions, Molecular Imaging has become aware of a potential ... Class II
Apr 22, 2016 Biograph mCT-S(64) 3R, MATERIAL NUMBER 10248669 The Siemens Biograph TrueP... Siemens Medical Solutions, Molecular Imaging has become aware of a potential ... Class II
Apr 22, 2016 BIOGRAPH 40 TruePoint w/TrueV, Material Number 10097304 The Siemens Biograph... Siemens Medical Solutions, Molecular Imaging has become aware of a potential ... Class II

View all 65 device recalls →

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious, there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious, the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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