Siemens Medical Solutions USA, Inc recalls ARTIS one with a hybrid cable- An angiography system developed for diagnostic imaging and interventional procedures. Material…
Examination room monitor connected with the hybrid cable may have a display issue and no image function is available
Read the official notice →- Date
- 2023-05-03
- Country
- United States
- Brand
- Siemens Medical Solutions
- Product
- ARTIS one with a hybrid cable- An angiography system developed for diagnostic imaging and interventional procedures. Material Number:…
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution in the states of FL, SD, PR and the…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2023-08-02
USSiemens Medical Solutions USA, Inc recalls Cios Select VA 21 with FD- A Mobile X-ray system intended for use in Operating room, Traumatology, Endoscopy, Intensive Care…
Incorrect glue was applied on the plexiglass sheet on the single tank cover assembly could potentially fall off and the ingress of liquid may occur, the risk of electric shock exists (e.g., ingress of a large amount of…
FDA · DeviceSiemens Medical Solutions USA, IncWorldwide - US Nationwide distribution in the states of FL, GA, KS, MN, NC, NY…Official notice →- 2023-05-31
- US
Siemens Medical Solutions USA, Inc recalls Luminos Agile Max (VE10, VF10, VF11)
Under certain unlikely circumstances during a fluoroscopic examination, the imaging system Fluorospot Compact might sporadically display an incorrect air kerma/air kerma rate related to the patient reference point,…
FDA · DeviceSiemens Medical Solutions USA, IncUS Nationwide - Worldwide DistributionOfficial notice → - 2023-05-10
- US
Siemens Medical Solutions USA, Inc recalls ARTIS pheno systems with a Siemens Healthineers table or Trumpf/MAQUET table (OEM)- Angiography systems developed for single…
If, during the procedure, X-ray has been released and a reference image has been stored, the following issue may occur: If "Adjust C-arm to Ref" is activated when the C-Arm is positioned outside of the working range…
FDA · DeviceSiemens Medical Solutions USA, IncWorldwide - US Nationwide distribution.Official notice → - 2023-04-05
- US
Siemens 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 →
Other drugs & medical recalls in the United States
- 2023-05-04
- US
Walker Edison Furniture Recalls Twin Over Twin Bunk Beds Due to Fall and Impact Hazards
The wooden slats supporting the bunk beds can break while in use, posing fall and impact hazards.
- 2023-05-03
- US
Draeger Medical Systems, Inc. recalls Draeger Infinity M300 and M300+, for use with the ICS to monitor ECG and pulse oximetry on ambulatory and non-ambulatory adult and…
The software on the Infinity CentralStation drops peaks on narrow waveforms causing the Infinity M300 to fail to meet Frequency and Impulse Response requirements. In this condition, ECG waveforms with unusually narrow…
- US
FUJIFILM Healthcare Americas Corporation recalls FujiFilm FDR AQRO (Model DR-XD1000)- A digital mobile X-ray system intended for use in general purpose radiography for…
Arm which holds the tube head in place is susceptible to breaking, if the device breaks it could potentially cause serious harm or injury to the patient and/or user.
- US
Mani, Inc. - Kiyohara Facility recalls Mani Trocar Kit, Model MTK23S and Model MTK25S There are 3 kits contained in one box, and sterile 1 kit consists of 3 pcs. trocar…
A packaging defect may compromise the sterile barrier.
FDA · DeviceMani, Inc. - Kiyohara FacilityDistribution in US - 1 consignee in MissouriOfficial notice → - US
Wright Medical Technology, Inc. recalls stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A221RT, bone stabilization and fixation
Two lots of Ortholoc 3Di Fusion plates contain incorrect dorsiflexion descriptions laser marked on the parts.
- US
Covidien LP recalls VersaOne Reusable Positioning Cannula 11mm Standard, Model Number RC11STS
There is a manufacturing non-conformance that may result in a metal shaving (burr) on the inside of the VersaOneTM Reusable Positioning Cannula, located where the Cannula and Body components are welded together.
FDA · DeviceCovidien LPWorldwide - US Nationwide distribution in the states of NC and the countries…Official notice →