🏥 Medical Devices Class I - Dangerous
When measuring a lesion on an unmagnified mammography image then performing the same measurement on an image magnified by the Hologic imager (different image), the measurements are not the same.
All Recalls
95,094 total recalls in our database
Zyston¿ Transform Instrument Case. Model Number PCR8200-2101. Device labeled sterile.
Zimmer Biomet Spine
🏥 Medical Devices Class I - Dangerous
Zimmer Bioment Spine, Inc. announces a voluntary field action for the Zyston¿ Transform Instrument Case and Zyston¿ Transform Implant Kit because the locking mechanism on the implant is not functioning as intended.
Brilliance CT 16 Power Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Philips Medical Systems (Cleveland)
🏥 Medical Devices Class I - Dangerous
Software defect causing intermittently slow response of Host.
Zyston¿ Transform Implant Kit. Model Number PCR8200-3101. Device labeled sterile.
Zimmer Biomet Spine
🏥 Medical Devices Class I - Dangerous
Zimmer Bioment Spine, Inc. announces a voluntary field action for the Zyston¿ Transform Instrument Case and Zyston¿ Transform Implant Kit because the locking mechanism on the implant is not functioning as intended.
🏥 Medical Devices Class I - Dangerous
The rear gradation scale was screen printed upside down on the flowmeter gauge.
Merge PACS software. Product was distributed under the AMICAS label, Brighton, MA, but labeling was later changed to Merge Healthcare, Hartland, WI.
Merge Healthcare
🏥 Medical Devices Class I - Dangerous
The patient name in the Halo title bar and the thumbnails do not match the name on displayed images.
🏥 Medical Devices Class I - Dangerous
An increase in the number of da Vinci EndoWrist Stapler complaints where the customer experienced a Stapler Firing Failed message as well as review of da Vinci Xi Surgical System logs found an increased trend
Stratus¿ CS STAT Fluorometric Analyzer-microprocessor-controlled instrument that measures certain analytes in body fluids for in vitro diagnostic use. Assays include ~hCG, CRP, CKMB, cTNI, D-Dimer, Myoglobin, and pBNP. SMN: 10444834, 10453531
Siemens Healthcare Diagnostics
🏥 Medical Devices Class I - Dangerous
Software defect, where either an Above Assay Range or an inaccurate value could potentially be reported, in the Stratus CS Acute Care Diagnostics System regarding TestPak calibration and quality control (QC) status when a TestPak is due to expire within 48 hours.
🏥 Medical Devices Class I - Dangerous
An internal review of an available product found that the Information For Use only contained English and Japanese languages when a CE-marked 23 language version was expected.
🏥 Medical Devices Class I - Dangerous
The firm recently identified a quality issue with the Junction box used in the Invacare Bariatric Bed. They discovered that the Junction Box may omit sparks which could result in a fire in the presence of flammable materials.
MX 16-slice whole body computed tomography X-ray system. Imaging diagnostic tool.
Philips Medical Systems (Cleveland)
🏥 Medical Devices Class I - Dangerous
The following issues have been found in MX 16-slice systems with software version 1.1.4.21426: 1. During the filming operation on MX16-slice console software, the clipboard used for copying and pasting images is not cleared between patients. If the operator fails to copy the current patients images before pasting, a previous patients images may be present in the clipboard and be copied onto the film of the current patient. 2. During the Bolus Tracking scan, if the Auto Voice in Tracker scan is enabled, the Tracker scan will be aborted unexpectedly and the diagnostic scan after the tracker scan needs to be manually started. 3. If the scan protocol with SAS (Spiral Auto Start) function is selected to plan the scan, the SAS option may not be displayed on the Contrast tab of the scan protocol parameter area or the SAS option is displayed but not enabled as pre-configured in the protocol. This issue only occurs on the first helical scan after system startup that applies SAS function
Brilliance iCT, Model No. 728306; To produce cross-sectional images of the body.
Philips Medical Systems (Cleveland)
🏥 Medical Devices Class I - Dangerous
Software issues in versions v4.1 .3/4.1.5 in the Philips Brilliance iCT) iCT SP products that, could affect the performance of the equipment.
🏥 Medical Devices Class I - Dangerous
After a few seconds of polishing with moderate force, parts of the OptraPol cup are breaking away. OptraPol Small Flame is also affected. Two complaints were filed referring to OptraPol, claiming that the abrasive polishers wear faster than expected.
Ingenuity Core Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Philips Medical Systems (Cleveland)
🏥 Medical Devices Class I - Dangerous
Software defect causing intermittently slow response of Host.
🏥 Medical Devices Class I - Dangerous
Several customer complaints about amplification performance issues when using different batches of MagSil with the NucliSENS easyMAG extraction platform.
Stryker Orthopaedic is voluntarily recalling the Triathlon Modular Handle because analysis revealed that the press fit specifications between the dowel pin and the mating hole in the shaft were not being achieved potentially resulting in disassociation from the instrument.
🏥 Medical Devices Class I - Dangerous
An increase in the number of da Vinci EndoWrist Stapler complaints where the customer experienced a Stapler Firing Failed message as well as review of da Vinci Xi Surgical System logs found an increased trend
Ingenuity Core128 Model No. 728323; To produce cross-sectional images of the body.
Philips Medical Systems (Cleveland)
🏥 Medical Devices Class I - Dangerous
Software issues in v4.1.3/4.1.4/4.1.5 in the Philips Ingenuity CT products that could affect the performance of the equipment.
Incorrect CO2 readings with some patient monitors.
Football helmets
Xenith LLC, of Detroit, Mich.
🏠 Consumer Products Class II - Moderate
The shells of the football helmets can crack, posing a risk of head injuries to football players.