Hologic Inc recalls Horizon X-Ray Bone Densitometer (DXA) Models: Horizon-A, Horizon-W, Horizon-WI, Horizon-C, Horizon-CI, Horizon-A-CN, Horizon-W-CN,…
Non-conformance pertains to electromagnetic compatibility requirements according to the international technical standard IEC 60601-1-2 for the safety and essential performance of medical electrical equipment, where the…
Read the official notice →- Date
- 2024-07-24
- Country
- United States
- Brand
- Hologic
- Product
- Horizon X-Ray Bone Densitometer (DXA) Models: Horizon-A, Horizon-W, Horizon-WI, Horizon-C, Horizon-CI, Horizon-A-CN, Horizon-W-CN,…
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide and the countries of India, Australia,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Hologic recalls
- 2024-12-18
USHologic, Inc recalls Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog Number: F0101
IFU was not provided with the Sizer Set sterilization tray Revised Sterilization Instructions for Sizer Set
- 2024-12-04
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Hologic, Inc recalls BioZorb Marker. Radiographic soft tissue marker.
Firm received reports of adverse events/complications that include serious injuries, such as pain, infection, rash, device migration, device erosion, seroma, and discomfort.
- 2024-10-02
- US
Hologic Inc recalls Selenia Dimensions/ 3Dimensions-Digital breast tomosynthesis Software Version Dimensions 1.12.0 and 3Dimensions 2.3.0 system software as…
Identified an issue with Selenia Dimensions 1.12.0 and 3Dimensions 2.3.0 system software when used in combination with C-View software in which the quality of the final C-View synthesized 2D image is impacted and may…
FDA · DeviceHologic IncWorldwide distribution - US Nationwide and the countries of Belgium, Canada,…Official notice → - 2024-05-15
- US
Hologic, Inc recalls BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic marking of sites in soft tissue. 1) F0405 BioZorb Marker 4cm x…
Safety Information: Complaints describe complications/adverse events that include pain, infection, rash, device migration, device erosion, seroma, discomfort, or other complications from feeling the device in the…
- 2024-04-03
- US
Hologic, Inc. recalls Aptima CMV Quant Assay, Reference numbers: AW-22600-001, AW-25509-001, and AW-26381-001 Amplification Reagent, Enzyme Reagent, Promoter…
Use of assay along with plasma specimen may result in error code which would invalidate sample.
FDA · DeviceHologic, Inc.Worldwide - US Nationwide distribution in the states of CA, CT, FL, ID, IL,…Official notice → - 2024-01-31
- US
Hologic, Inc. recalls PANTHER FUSION System REF 9121010000 The Panther System is an integrated nucleic acid testing system which fully automates all steps…
Due to potential false positive Flu B results when a sample was also SARS-CoV-2 positive.
FDA · DeviceHologic, Inc.Worldwide - U.S. Nationwide distribution including in the states of AK, AR,…Official notice →
Other drugs & medical recalls in the United States
- 2024-07-24
- US
B. Braun Medical, Inc. recalls OUTLOOK PUMP SET 3 CARESITE LADS 133 IN.-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication…
Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of…
FDA · DeviceB. Braun Medical, Inc.Worldwide distribution - US Nationwide and the country of Canada.Official notice → - US
Greiner Bio-One North America, Inc. recalls VACUETTE¿ TUBE 8 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, non-ridged
The firm received reports that some blood collection tubes have experienced issues with clotting and poor separation due to missing additive. The failure of the device would likely require sample recollection which…
FDA · DeviceGreiner Bio-One North America, Inc.Nationwide Distribution to states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA,…Official notice → - US
CareFusion 303, Inc. recalls BD Pyxis: MedStation ES (Main), REF: 323; MedStation ES Tower, REF: 352; Anesthesia Station ES, REF: 327; CII Safe ES, REF: 1116-00; CII…
If automated dispensing cabinets have specific software versions, and Component Manager was configured to "installed mode", and software patch KB 5033688 was installed in the production environment, then this will will…
FDA · DeviceCareFusion 303, Inc.Worldwide - US Nationwide distribution including in the states of OR, KS, NE,…Official notice → - US
Howmedica Osteonics Corp. recalls UNITRAX Endoprosthesis Head Component - 43mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-043
Mislabeled: the size on the package label of the UNITRAX¿ Endoprosthesis Head Component potentially may not match the device within the packaging. This product mix only involves the three (3) sizes (43mm, 42mm, and the…
FDA · DeviceHowmedica Osteonics Corp.Worldwide distribution - US Nationwide and the countries of Australia, Hong…Official notice → - US
Abbott Medical recalls Abbott Proclaim XR 5 Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only
The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.
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SEASPINE ORTHOPEDICS CORPORATION recalls Brand Name: Meridian Angled Awl Fixed Product Name: Angled Awl Fixed Model/Catalog Number: RA2-003015 Product Description:…
Insufficient weld around the cap component of the instrument is insufficient to withstand impaction forces.
FDA · DeviceSEASPINE ORTHOPEDICS CORPORATIONThe product was distributed to the following US states: Nevada, Colorado,…Official notice →