GE Healthcare became aware of a potential issue associated with the LOGIQ e system. Image data from one patient has the potential to be linked to the patient ID of another patient.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Notes associated with prescription are not printed to the prescription or to the patient chart.
Class I - Dangerous
Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involving the EZTest Steam and Smart-Read Biological Indicators (BI) because the readout time is not in specification with the label claims.
Class I - Dangerous
Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps.
Mesa EZtest BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use in determining the efficacy of steam sterilization processes.
Mesa Laboratories, Inc., Bozeman Manufacturing Facility
Class I - Dangerous
Mesa EZTest , Self-contained steam biological indicator, are recalled because Mesa recently determined that the read out time is not in specification with the label claims.
Class I - Dangerous
When torque is applied to the Articulated Driver at the maximum angle, the cross pin may shift out of position, potentially leading to disassembly of the instrument.
Class I - Dangerous
Potential to electrostatic discharged (ESD)
Inspira AIR Balloon Dilation system. Size 12 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
Acclarent
Class I - Dangerous
Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps.
Class I - Dangerous
The recall was initiated because Beckman Coulter has identified a software error on AU5800 analyzers with the Automation Ready (AR) Sampler Kit. This software error results in the failure of the concentrated wash solution pump to stop, creating an overflow or leak on each analyzer unit.
Class I - Dangerous
Sotera Wireless, Inc. is recalling the ViSi Mobile Monitoring System due to the potential for the Chest Sensor to cause a blister wound.
Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involving the EZTest Steam and Smart-Read Biological Indicators (BI) because the readout time is not in specification with the label claims.
Inspira AIR Balloon Dilation system. Size 14 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
Acclarent
Class I - Dangerous
Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps.
Class I - Dangerous
Siemens initiate this recall due to a potential issue when using the sDIS matching rules of the syngo Dynamics Information System version 9.5 or VA10A with modality device configured to end study at association close. Images or DICOM SR objects sent from a modality device to syngo Dynamics may not be saved when the modality is configured at syngo Dynamics to end study at association close, and whe
Class I - Dangerous
Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involving the EZTest Steam and Smart-Read Biological Indicators (BI) because the readout time is not in specification with the label claims.
Malfunction of slap hammer.
Inspira AIR Balloon Dilation system. Size 16 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
Acclarent
Class I - Dangerous
Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps.
In vitro diagnostic test kit may exhibit invalid internal negative control results.
On March 28, 2013, Custom Spine, Inc. issued a minor removal of a lot of 18 screws that were found to be out of specification. The screw length was 5 mm shorter in length than the required specification for the screw size. The product is laser marked 8.5mm X 45mm, but its length measured 40mm.
A complaint was received from the field, that the drill guide was etched incorrectly, 12mm etch instead of 18mm drill guide. The firm identified that this constituted a field action and retrospectively reported this action.
Class I - Dangerous
Stryker Osteosynthesis has become aware that LEFT GAMMA3 nails are marked as right nails.