Siemens Medical Solutions USA, Inc recalls ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ARTIS icono ceiling Model 11328100. ARTIS icono…
During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the…
Read the official notice →- Date
- 2026-06-10
- Country
- United States
- Brand
- Siemens Medical Solutions
- Product
- ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ARTIS icono ceiling Model 11328100. ARTIS icono floor Model…
- Classification
- Class II
- Units
- US and Worldwide
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Siemens Medical Solutions recalls
- 2026-07-08
USSiemens Medical Solutions USA, Inc recalls ARTIS icono ceiling. Model Number: 11328100.
Potential issue with the Display ceiling suspension (DCS Fix XL) that holds the monitor in place. Over time some screws that keep the monitor attached to the suspension may gradually loosen.
FDA · DeviceSiemens Medical Solutions USA, IncUS Nationwide distribution in the states of CA, GA, IA, IN, LA, MO, NC, NY,…Official notice →- US
Siemens Medical Solutions USA, Inc recalls ARTIS icono floor. Model Number: 11327700.
Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.
- 2026-04-22
- US
Siemens Medical Solutions USA, Inc recalls ARTIS Pheno VE30A and VE40A, Model 10849000
During 3D acquisitions, lighter and darker patient images may be captured, which may result in less accurate 3D reconstruction. The variation of brightness is a result of a constant unregulated medium dose and the…
- 2026-04-15
- US
Siemens Medical Solutions USA, Inc recalls ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700.
During patient examinations, the system may sporadically display a major increase of the x-ray dose applied to the patient. Despite the reported dose showing significantly higher, the actual applied x-ray dose levels…
FDA · DeviceSiemens Medical Solutions USA, IncWorldwide - US Nationwide distribution.Official notice → - 2026-02-11
- US
Siemens Medical Solutions USA, Inc recalls NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
FDA · DeviceSiemens Medical Solutions USA, IncWorldwide distribution - US Nationwide and the countries of Canada, Costa…Official notice → - 2026-02-04
- US
Siemens Medical Solutions USA, Inc recalls Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 11574002; With Software Version…
Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images, there is the possibility that an image of a previous patient may be processed.
FDA · DeviceSiemens Medical Solutions USA, IncWorldwide - US Nationwide distribution in the states of AK, CA, IL, MN, NY,…Official notice →
Other drugs & medical recalls in the United States
- 2026-06-10
- US
Fresenius Kabi USA, LLC recalls LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.
Potential software anomaly that can cause the pump to report a false battery-health value (typically 69%) and trigger a battery-depletion alarm that will shut down the pump unless it is reconnected to AC mains power.
FDA · DeviceFresenius Kabi USA, LLCUS Nationwide distribution in the states of CA, CO, FL, GA, GA, ID, IL, MD,…Official notice → - US
KAYSERBETTEN GMBH & CO. KG recalls Pediatric care bed; Product Designation: KayserBett IDA;
If the adjustment functions of the hand control, as instructed in the Manual, are not locked with the provided key when the patient (child) is unattended, there is an increased risk that the patient (child) or third…
- US
Draeger, Inc. recalls Atlan A350XL. Model Number: 8621600. anesthesia workstation
The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
FDA · DeviceDraeger, Inc.US distribution in WI, AR, MN, WI, CO, MA, PA, AZ, FL, NY, SD, ND.…Official notice → - US
SUN PHARMACEUTICAL INDUSTRIES INC recalls Xyvona (levorphanol tartrate tablets), 2mg, 100 Tablets, Rx only, Forte BioPharma, Manufactured by: Ohm Laboratories Inc., New…
Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona
- US
Lannett Company Inc. recalls Niacin Extended-release Tablets, USP, 1,000 mg, 90-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136,…
Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint.
- US
Guardian Drug Co. Inc. recalls HALEON CALCIUM CARBONATE TUMS ANTACID, Assorted Fruit Tablets, 1000 mg, 160-count bottle, Haleon, Warren, NJ 07059, UPC 3 07660 74610 2.
Presence of foreign substance: small metallic particles in chewable tablets.