Medical equipment, implants, and diagnostic devices
Mallinckrodt Manufacturing
Product was improperly labeled leading to improper storage.
Siemens Medical Solutions USA
Software error. In Sensis Vibe systems with software version VD10B, a software error can result in: problems generating a report and/ or - information from different examinations of the same patient being combined into one report. --- The error causes information from two examinations to be combined into one report. This does not result in a hazardous situation; however, if the erroneous report has been used for treatment or diagnosis, this can potentially result in an incorrect treatment or diagnosis.
Mis-pack. A size 6 Left 3DKnee Tibial Insert box and pouch contained a Size 8 right 3Dknee Tibial Insert.
Ion Beam Applications S.A.
Recall is being initiated to address on-site software installations not being performed consistently with IBA standard operating procedures.
Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream the Glenoid, i.e., to include a caution statement that the surgeon should ream on-axis and that reaming off-axis may result in instrument breakage.
Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream the Glenoid, i.e., to include a caution statement that the surgeon should ream on-axis and that reaming off-axis may result in instrument breakage.
Boston Scientific
Label on the affected devices incorrectly identifies the injection location as "above" the balloon when it should be below the balloon and "below" the balloon when it should be above the balloon
CareFusion 303
BD initiated the recall of Alaris PC unit model 8015 after the firm identified five scenarios which can result in the occurrence of Systems Error Code 255-16-275 and can potentially result in interrupted infusions.
Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream the Glenoid, i.e., to include a caution statement that the surgeon should ream on-axis and that reaming off-axis may result in instrument breakage.
Exactech
The firm determined that the labeling (surgical technique) should be updated to clarify the proper technique and instrumentation to remove the tamp assembly from the bone, i.e., to include a caution statement about the potential for instrument breakage if the tamp handle/guide is misused by impacting in retro-grade.
When samples are prepared using the PrepPlus or PrepPlus 2 sample preparation systems and then run on a Flow cytometer, there is an imprecision in the absolute counts on only the first tube in a run.
The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm
Under certain conditions, the cables used with the Hemo system during a patient procedure could stop displaying the patient SpO2 causing a slight delay in patient care.
ROTH MOBELI grab handles could detach and patient could fall if the EOS system operator does not follow instructions. Before each use, the operator must examine the vacuum safety indicator to check the vacuum is monitored and sufficient and the grab handle correctly attached. Do not use grab handles to help patient up. The handles are only for stabilizing the patients hand or arm in the EOS cabin.
Under certain conditions, the cables used with the Hemo system during a patient procedure could stop displaying the patient SpO2 causing a slight delay in patient care.
Smith & Nephew
The incorrect Loctite adhesive was used to assemble the impactor heads.
FANA200 kit lot TS 3577 was re-worked due to shortened shelf-life. The alert sticker on the kit box of the lot informed customers that the shelf-life had been shortened and referenced a letter sent to customers for more information, where the new expiration date was stated. The original kit box label remained on the kit box stating the original expiration date, the packaging did not display the correct expiration date.
Shimadzu Medical Systems Usa Com
Cracks may occur over time on the tube holding shaft near the base of the tube mounting flange.
da Vinci Xi(R) Surgical System Patient Side Carts (PSC) were shipped to the field with potentially under-torqued brake screws in a section of the system arms.
The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm