Siemens Medical Solutions USA, Inc recalls System Material # Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee multi-purpose 10094139 Artis zee biplane…
In rare cases, the system may only boot into backup mode after an abrupt shutdown and not reach full operating mode. This may result in a situation where it is necessary to cancel clinical treatment or to continue…
Read the official notice →- Date
- 2023-02-08
- Country
- United States
- Brand
- Siemens Medical Solutions
- Product
- System Material # Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee multi-purpose 10094139 Artis zee biplane 10094141 Artis…
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2023-04-05
USSiemens Medical Solutions USA, Inc recalls ARTIS pheno systems with a Siemens Healthineers table or a Trumpf/ MAQUET table-A Fluoroscopic X-Ray system. Material #…
In the event of any unintended table movement, the system may not detect the incorrect direction, could lead to the injury of a patient, staff member, operator, or equipment.
- 2023-03-01
- US
Siemens Medical Solutions USA, Inc recalls Luminos dRF Max with software VE10, VF10, VF11- A diagnostic imaging system for radiographic and fluoroscopic studie Model…
Potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or patients due to room configuration parameters of the system being set to default values
- 2023-02-22
- US
Siemens Medical Solutions USA, Inc. recalls SIEMENS Biograph mCT: a) Flow 64-4R Seismic, b) S(40)-3R Seismic, c) S(64)-3R Seismic, d) S(40)-4R Seismic, e) S(64)-4R…
This is a potential problem with the locking mechanism that is used to secure the PET gantry in either its scanning or service position.
FDA · DeviceSiemens Medical Solutions USA, Inc.Worldwide distribution - US Nationwide and the countries of Japan, Chile,…Official notice → - 2023-02-01
- US
Siemens Medical Solutions USA, Inc recalls Software : myNeedle Guide 2D license, myNeedle Guide 2D AWP only Workflow license, or myNeedle Guide 3D license. Used on the…
In the syngo.CT VA40 and syngo.CT VA50 myNeedle Guide application, the order of the orientation labels head , center, and feet in the axial thick slice segments are erroneously swapped
- 2023-01-25
- US
Siemens Medical Solutions USA, Inc recalls Luminos Agile Max, Luminos dRF Max, and LUMINOS Lotus Max
There is potential for the footrest to detach from the patient table during use. Device intended to visualize anatomical structures by converting an Xray pattern into a visible image. The system has medical…
- US
Siemens Medical Solutions USA, Inc recalls ARTIS pheno, ARTIS icono biplane, and ARTIS icono floor
Mechanical connection between the tabletop and table base may be lost.
FDA · DeviceSiemens Medical Solutions USA, IncWorldwide distribution - US Nationwide and the countries of Armenia,…Official notice →
Other drugs & medical recalls in the United States
- 2023-02-08
- US
CooperSurgical, Inc. recalls BIOPSY MEDIUM 10ML, Reference Number 10620010 A, used for blastomere biopsy of cleavage stage embryos for Pre-implantation Genetic…
The affected product may contain a medium other than the Biopsy Medium. There is a risk that use of the Product from this lot could cause degradation of the embryo.
FDA · DeviceCooperSurgical, Inc.Global Distribution including countries of: Bahrain, Belgium, Bulgaria, Egypt,…Official notice → - US
Biomet, Inc. recalls (1) Vanguard Knee System PS Open Box Femoral; Left; 57.5 mm. Intended for Knee joint replacement prostheses. Item Number: 183122 EXPANDED…
Components Incorrectly labeled as either smaller or larger and incorrect side (right/left).
FDA · DeviceBiomet, Inc.International distribution to the countries of: Argentina, China, Costa Rica,…Official notice → - US
Carbon Medical Technologies, Inc. recalls Mammotome MammoStar Biopsy Site Identified, REF STAR1401
The label incorrectly identifies the product as STAR1401, a 1x3mm Barbell shaped marker pre-loaded in a 14 gauge needle, while the packaging contains STAR1402, a 1x5mm Tribell shaped marker pre-loaded in a 14 gauge…
FDA · DeviceCarbon Medical Technologies, Inc.US Nationwide distribution in the state of OHIO.Official notice → - US
Medtronic Navigation, Inc. recalls AxiEM" Non-Invasive Patient Tracker
Due to increasing complaint trend for the Non-Invasive Patient Tracker system where complaints analysis indicates that users are unable to successfully verify their navigation instruments during image-guided surgery.
FDA · DeviceMedtronic Navigation, Inc.Worldwide - U.S. distribution including in the states of AL, AR, AZ, CA, CO,…Official notice → - US
Turbett Surgical, Inc. recalls Turbett Surgical Container, TS1000: Indicated for enclosing other medical devices that are to be sterilized by a healthcare provider
Pod may have weld failures breaching the sterile barrier and result in the use of unsterile instruments leading to infection or other major injuries.
FDA · DeviceTurbett Surgical, Inc.US Nationwide distribution in the states of CA, IA, IN, NC, NH, NY, OH, LA,…Official notice → - US
Biomet, Inc. recalls OSS Modular Arthrodesis Nail, 7 Degree Collar Assembly with Locking Bolts-For use in the replacement of segmental defects of long bone,…
Product missing the four small locking collar bolts resulting in extension of surgery to find a replacement