Food, drugs, devices › Siemens Medical Solutions USA Inc.
Device recall: Biograph mCT S(40)-4R, Model Number 10248671
FDA enforcement event 71712 is a device recall by Siemens Medical Solutions USA Inc. of Knoxville, TN, initiated 14 Jul 2015 and classified Class II, with 8 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,153 device enforcement events initiated in 2015 carry the same class.
Status: Terminated, terminated 3 Mar 2016. Initiation: voluntary: firm initiated. Siemens Medical Solutions USA Inc. has 400 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Siemens Medical Solutions USA Inc., Knoxville, TN.
Reason for recall
"Emission computed tomography systems and computed tomography xray systems with optional ceiling mounts may be missing a locking ring."
Distribution
"Distributed in the state of Texas and the countries of Germany, France, Russia, Denmark, and Switzerland."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2331-2015 | Biograph mCT S(40)-4R, Model Number 10248671 | 1 unit | Class II | Terminated | 12 Aug 2015 |
| Z-2332-2015 | Biograph mCT S(64)-4R, Model Number 10248672 | 1 unit | Class II | Terminated | 12 Aug 2015 |
| Z-2333-2015 | Biograph mCT X-4R, Model Number 10248670 | 2 units | Class II | Terminated | 12 Aug 2015 |
| Z-2334-2015 | SYS IVK, Bio mCT-S(40) 3R->4R, Model Number 10250743 | 1 unit | Class II | Terminated | 12 Aug 2015 |
| Z-2335-2015 | Biograph mCT Flow Edge-4R, Model Number 10528955 | 3 units | Class II | Terminated | 12 Aug 2015 |
| Z-2336-2015 | Biograph 6-4R TruePoint w/ TrueV, Model Number 10097290 | 1 unit | Class II | Terminated | 12 Aug 2015 |
| Z-2337-2015 | Biograph 64-4R TruePoint w/ TrueV, Model Number 10097302 | 2 units | Class II | Terminated | 12 Aug 2015 |
| Z-2338-2015 | Biograph 64-3R TruePoint w/ TrueV, Model Number 10097301 | 1 unit | Class II | Terminated | 12 Aug 2015 |
Context
Other enforcement events for Siemens Medical Solutions USA Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 8 Jun 2026 | ARTIS icono ceiling. Model Number: 11328100. | Device | Class II | 1 |
| 20 May 2026 | ARTIS icono biplane. Model Number: 11327600. | Device | Class II | 3 |
| 12 Mar 2026 | ARTIS Pheno VE30A and VE40A, Model 10849000 | Device | Class II | 1 |
| 10 Mar 2026 | ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700. | Device | Class II | 1 |
| 9 Mar 2026 | ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system | Device | Class II | 2 |
| 29 Dec 2025 | Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 11574002; With Software Vers | Device | Class II | 2 |
| 19 Dec 2025 | SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS | Device | Class II | 4 |
| 5 Dec 2025 | LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471 | Device | Class II | 1 |
| 24 Oct 2025 | MAMMOMAT Revelation; | Device | Class II | 3 |
| 1 Oct 2025 | MAGNETOM Cima.X Upgrade. Model Number: 11689304. | Device | Class I | 1 |
All 400 events for Siemens Medical Solutions USA Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Emission computed tomography systems and computed tomography xray systems with optional ceiling mounts may be missing a locking ring."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Distributed in the state of Texas and the countries of Germany, France, Russia, Denmark, and Switzerland."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 3 Mar 2016. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.