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24 reported ongoing
24 records in this archive. Latest source date Jul 22, 2026.
FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
Software issue may cause the ruler measurement to be inaccurate.
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution in the states of NY, VA, KS, OR, OH, and the country of Australia.
It was found that the contacts of the electromagnetic contactors used inside the cabinet of the X-ray high-voltage generator were welded, and the current might continue to be supplied to the power supply circuit even if the power of the device is cut off. A...
Class IIReported ongoing
Distribution: US Nationwide distribution in the states of AK, CA, CT, FL, IL, NH, OH, WI.
It was found that the shaft for mounting the X-ray tube unit on the support may break. In addition, it was found that the protective parts might not work effectively only when the shaft was broken while being operated toward the front while lifting.
Class IIReported ongoing
Distribution: Domestic: AK, CA, FL, IL, MA, NH, OH, WI.
Devices had an unapproved slabbing software function enabled for use.
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Chile, Ecuador.
The incorrect computed patient age is showing in VX for patients less than 3 months old.
Class IIReported ongoing
Distribution: Domestic: AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, MA, MN, MO, MS, NC, NJ, NY, OH, OK, OR, TN, TX, VT, WA, WI, WV, WY. International: Australia, Belgium, Brazil, Fran...
AC adapters of Noblus can heat up, and cause smoke in the worst case, when an excessive mechanical stress is applied to the socket for power cable (frequent insertion/removal of the power cable).
Class IIReported ongoing
Distribution: US Nationwide distribution.
Bolts on the CH-200 tube may rupture due to fatigue failure, causing the tube support to fall, could result in patient injury
Class IIReported ongoing
Distribution: US Nationwide distribution in the states of AK, CA, FL, IL, NE, NH, OH, TN, WI.
Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements.
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide, including Puerto Rico and the countries of Australia, Belgium, Brazil, Canada, Colombia, Ecuador, France, Germany, India, Italy, Mexico, ...
Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements.
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide, including Puerto Rico and the countries of Australia, Belgium, Brazil, Canada, Colombia, Ecuador, France, Germany, India, Italy, Mexico, ...
Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements.
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide, including Puerto Rico and the countries of Australia, Belgium, Brazil, Canada, Colombia, Ecuador, France, Germany, India, Italy, Mexico, ...
Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements.
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide, including Puerto Rico and the countries of Australia, Belgium, Brazil, Canada, Colombia, Ecuador, France, Germany, India, Italy, Mexico, ...
Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements.
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide, including Puerto Rico and the countries of Australia, Belgium, Brazil, Canada, Colombia, Ecuador, France, Germany, India, Italy, Mexico, ...
Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements.
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide, including Puerto Rico and the countries of Australia, Belgium, Brazil, Canada, Colombia, Ecuador, France, Germany, India, Italy, Mexico, ...
The LV Mass (2D Bullet) equation may be calculated incorrectly, resulting in a variance in the mass of the left ventricle (LV Mass). If used as a main factor for diagnosis, there is a risk of misdiagnosis or incorrect treatment plan of a patient, resulting ...
Class IIReported ongoing
Distribution: US domestic distribution nationwide. International distribution to Israel.
The LV Mass (2D Bullet) equation may be calculated incorrectly, resulting in a variance in the mass of the left ventricle (LV Mass). If used as a main factor for diagnosis, there is a risk of misdiagnosis or incorrect treatment plan of a patient, resulting ...
Class IIReported ongoing
Distribution: US domestic distribution nationwide. International distribution to Israel.
When the key switch is turned on, the exposure conditions are set to the default values (85kV, 1.6 mAs, approx. 0.13mGy@ SID 1m) intended for adult chest imaging. In addition, if exposure conditions are set from the console while the key switch is off, the ...
Class IIReported ongoing
Distribution: US Nationwide and Worldwide
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.
Class IIReported ongoing
Distribution: US Nationwide distribution.
Error 00003050 or 00003052 may occur during scanning, the captured images will not be reconstructed and the Raw Data will not be displayed in the work list.result, may result in the need for additional scanning to capture the images properly for reconstruct...
Class IIReported ongoing
Distribution: US Nationwide Distribution
Error 00003050 or 00003052 may occur during scanning, the captured images will not be reconstructed and the Raw Data will not be displayed in the work list.result, may result in the need for additional scanning to capture the images properly for reconstruct...
Class IIReported ongoing
Distribution: US Nationwide Distribution
Error 00003050 or 00003052 may occur during scanning, the captured images will not be reconstructed and the Raw Data will not be displayed in the work list.result, may result in the need for additional scanning to capture the images properly for reconstruct...
Class IIReported ongoing
Distribution: US Nationwide Distribution
These examples come from this result page and are not a ranking of every recall reason.
This archive contains 24 records, including 24 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.
Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.
A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.
This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.
Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.