Siemens Medical Solutions USA, Inc. recalls Symbia Intevo Bold and Symbia Intevo 6 SPECT/CT Systems
There is a quality issue with the three bolts that hold the CT balancing weights, which could create a safety issue.
Read the official notice →- Date
- 2022-04-13
- Country
- United States
- Brand
- Siemens Medical Solutions
- Product
- Symbia Intevo Bold and Symbia Intevo 6 SPECT/CT Systems
- Classification
- Class II
- Units
- Distribution OUS only to El Salvador, France, Germany, Japan, Taiwan, and UK.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2022-04-27
US
Siemens Medical Solutions USA, Inc recalls Artis icono floor in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and…
Five potential software issues affecting Artis pheno and Artis icono systems in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). The potential software errors are related to the block…
US
Siemens Medical Solutions USA, Inc recalls Artis zee floor MN, Model Number 10094142
If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message "TUBE HOT, have a…
US
Siemens Medical Solutions USA, Inc recalls SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 & 11061628…
Software error may result in sporadic problems causing scanning workflow interruptions, unexpected user notifications and image artifacts. Sporadic software errors may also occur during interventional workflows.…
- 2022-04-13
US
Siemens Medical Solutions USA, Inc recalls YSIO X.Pree
For the automated multi-image-acquisition procedure Ortho x-ray collimation is set in a preparative stage for the entire examination area prior to the exam. During acquisition of each individual x-ray image, the x-ray…
FDA · DeviceSiemens Medical Solutions USA, IncUS Nationwide, Worldwide distributionOfficial notice →- 2022-04-06
US
Siemens Medical Solutions USA, Inc recalls Ysiosystem with VC10 software version, Model Number 10281013. Radiographic system
Siemens Healthineers has identified a software error in previous software version VB10 for the Ysio fully automated system. The unit may process incorrect internal values for the position of its ceiling tube stand. If…
- 2022-03-23
US
Siemens Medical Solutions USA, Inc. recalls Diagnostic Ultrasound System, ACUSON Juniper, UDI: (01)04056869152059, Model: 11335791, Rx, CE Ultrasound imaging system…
The clip store function in the ultrasound imaging system does not work when the system has a disk full error. This could cause a delay in treatment if the ultrasound system is unable to save clips as study…
FDA · DeviceSiemens Medical Solutions USA, Inc.Worldwide distribution: US (nationwide) and countries of: Algeria, Andorra,…Official notice →
Other drugs & medical recalls in the United States
- 2022-04-13
US
DRG International, Inc. recalls C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- or citrate plasma) and urine. Catalog # EIA-1293
ODs of the standards too low(< 0.6 ODmax) may cause invalid runs, delayed patient results are possible
US
Abbott recalls Amplatzer Steerable Delivery Sheath
Instructions for use were updated.
US
Ventana Medical Systems Inc recalls BenchMark ULTRA and DISCOVERY ULTRA Instruments
Potential for Fluid Leak inside a staining system that could cause an electrical short circuit of the General Purpose Input/ Output Board's J1 Connector that could result in smoke and fire.
FDA · DeviceVentana Medical Systems IncUS: CA, IL, PA, FL, AZ, NY, OH, CO, AR, NC, MD, AL, AK, LA, IA, MN, MA, ND,…Official notice →US
WHPM Inc. recalls First SIGN SARS-CoV-2 Antigen Test
Frm became aware that a customer complaint was reported to US FDA that SARS-CoV-2 Antigen Tests were sold domestically by a pharmacy in California. These Antigen Tests have not received FDA Emergency Use Authorization,…
US
Abbott Laboratories recalls ARCHITECT STAT Myoglobin Calibrators, RES 2K43-01 The ARCHITECT STAT Myoglobin Calibrators are for the calibration of the ARCHITECT…
This calibrator lot did not meet acceptance criteria during ongoing stability testing. When a calibration is performed with this lot, controls may exceed the specified range in the Instructions for Use (IFU).
FDA · DeviceAbbott LaboratoriesWorldwide Distribution: US (nationwide) and OUS (foreign) including countries…Official notice →US
Brius Technologies Inc. recalls Brius Patient Specific Brackets (components in a set of custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom Made…
Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to completing the standard design control process, being documented, and released.