Class IIOngoingZ-2168-2026
Hologic, Inc recalls 3DIMENSIONS MAMMOGRAPHY SYSTEM
Complaints have been received of systems developing loose, missing, or broken internal bolts over time.
Hologic, IncMAMay 20, 2026
Recalls in Massachusetts
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 37–48 of 371 recalls
Class IIOngoingZ-2167-2026
Hologic, Inc recalls SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC
Complaints have been received of systems developing loose, missing, or broken internal bolts over time.
Hologic, IncMAMay 20, 2026
Class IIOngoingZ-2005-2026
Siemens Healthcare Diagnostics Inc recalls epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System
Use of the affected product can result in discrepant low pH and measured Total Carbon Dioxide (mTCO2) results and corresponding calculated values in arterial, venous, and capillary patient samples.…
Siemens Healthcare Dia…MAMay 6, 2026
Class IIOngoingZ-1995-2026
Straumann USA LLC recalls Straumann n!ce Zr
Includes an incorrect screw seat interface.
Straumann USA LLCMAMay 6, 2026
Class IIOngoingZ-1994-2026
Straumann USA LLC recalls Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010.0304.…
Includes an incorrect screw seat interface.
Straumann USA LLCMAMay 6, 2026
Class IIOngoingZ-1969-2026
Philips North America recalls Philips Upgrade to MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782130.
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE s…
Philips North AmericaMAMay 6, 2026
Class IIOngoingZ-1968-2026
Philips North America recalls Philips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1. Model Number…
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE s…
Philips North AmericaMAMay 6, 2026
Class IIOngoingZ-1967-2026
Philips North America recalls Philips SmartPath to dStream for XR and 3.0T with MR Elastography (MRE). 1. Model N…
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE s…
Philips North AmericaMAMay 6, 2026
Class IIOngoingZ-1966-2026
Philips North America recalls Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (…
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE s…
Philips North AmericaMAMay 6, 2026
Class IIOngoingZ-1965-2026
Philips North America recalls Philips SmartPath to dStream for 1.5T with MR Elastography (MRE). 1. Model Number (…
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE s…
Philips North AmericaMAMay 6, 2026
Class IIOngoingZ-1964-2026
Philips North America recalls Philips MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782120. 2. M…
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE s…
Philips North AmericaMAMay 6, 2026
Class IIOngoingZ-1963-2026
Philips North America recalls Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358…
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE s…
Philips North AmericaMAMay 6, 2026