Class I - Dangerous
Unusually high number of total images/unassigned events may require additional time and effort for the operator to review all the images and may cause a delay in reporting the results.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Proteus 235, ProteusPLUS or Proteus ONE produces and delivers a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
Ion Beam Applications S.A.
Class I - Dangerous
When switching from Pencil Beam Scanning treatment mode to Uniform Scanning treatment mode, the tuning setpoints of the scanning magnets are not always taken into account when the proton beam is requested. The mismatch between the setpoint and feedback leads to an error message. Depending on user action, two scenarios are possible: 1. The user resumes the treatment field without analyzing the cause for the error message. This may lead to under-irradiation. 2. The user reboots the Scanning Magnets Power Supply Electronic Unit. This may lead to delay in patient treatment and the patient may need to be re-aligned, which leads to an additional X-ray dose.
Class I - Dangerous
Potential failure of sterile packaging seal.
T4 Pullover Toga, L/XL; Catalog Number: 0400-720-000 Sterile personal protection garment
Stryker Instruments Div. of Stryker
Class I - Dangerous
Separation of material layers may occur, causing a potential risk of exposure to contaminants.
TCC-EZ, Total Contact Cast System, Model No. TCC2-4051
Integra LifeSciences
Class I - Dangerous
A quarantined lot of the devices was released for sale. Devices from this lot may experience increased exothermic reaction causing higher levels of heat output which exceed the product specifications.
ADVIA Centaur CA 125II Assay; Cat No. 09427226, SMN 10310443 (1-pack/100 tests); Cat no. 01678114, SMN 10315696 (5-pack/500 tests)
Siemens Healthcare Diagnostics
Class I - Dangerous
Upon dilution, some patient samples may exhibit over-recovery outside the representative data provided in the assay instructions for use.
T4 Zipper Toga, Regular; Catalog number: 0400-830-000 Sterile personal protection garment
Stryker Instruments Div. of Stryker
Class I - Dangerous
Separation of material layers may occur, causing a potential risk of exposure to contaminants.
There is a potential for the slope of the standard curve to fail to meet the assay validation requirements for the assay.
Medtronic DxTerity Diagnostic Catheter, JL 4.0, REF DXT5JL40, marked with 6F color code on box.
Medtronic Vascular
Class I - Dangerous
The color coded French size indicator on the outer box may incorrectly reflect a 6 French size, rather than the correct 5 French size. The catheters inside the carton are the correct DXT5JL40 item, the inner pouch has correct 5F labeling, information and configuration details.
Class I - Dangerous
A potential commingle that could result in the product in the package not matching the product on the outer label.
Accelerate PhenoTest BC kit, Ref #10101018. The firm name on the label is Accelerate Diagnostics, Tucson, AZ. A multiplexed in-vitro diagnostic test intended for use with the Accelerate Pheno system.
Accelerate Diagnostics
Class I - Dangerous
The kits may produce an elevated rate of false positive calls for the Staphylococcus aureus identification probe (SAU).
Incorrect product labeling. Product labeled as 6mm x 2cm balloon are packaged with a 4mm x 4 cm balloon label and vice-versa.
Double Blade Shoe F/Unigraft Knife 1.5 Thick X 9MM SKU 6500009 Used to achieve epithelial graft in the oral cavity.
Ace Surgical Supply Co.
Class I - Dangerous
The product inside the package is incorrect. A single blade shoe was mistakenly packaged instead of a double blade.
Class I - Dangerous
The surgical cassette contained extra-large white grommets making the 3.8 mm and 6.5mm dental burrs wobble within the grommets in the surgical cassette.
Quick connect feature of instruments may be unable to connect to the male features of Flex Arm Adaptors, Insight Retractors, or other mating parts.
T4 Zipper Toga, (L/XL); Catalog Number: 0400-820-000 Sterile personal protection garment
Stryker Instruments Div. of Stryker
Class I - Dangerous
Separation of material layers may occur, causing a potential risk of exposure to contaminants.
ZMS Intramedullary Fixation Smooth Guide Wire Bullet Tip 3.0 mm Diameter, 100 cm Length; Item Number: 47-2237-038-00
Zimmer Biomet
Class I - Dangerous
Potential failure of sterile packaging seal.
T4 Pullover Toga, X-Large; Catalog Number: 0400-770-000 Sterile personal protection garment
Stryker Instruments Div. of Stryker
Class I - Dangerous
Separation of material layers may occur, causing a potential risk of exposure to contaminants.
MicroVue SC5b-9 Plus EIA (CE-IVD), Model A029. An enzyme immunoassay for the quantitation of SC5b-9 complex present in human plasma or serum.
Diagnostic Hybrids
Class I - Dangerous
A component of the kit was found to contain bacterial contamination.
Incidents of stem trial breakage were reported to the firm suggesting that these fractures all occurred during insertion/impaction or extraction of the humeral stem trial whiling preparing the humeral canal and/or trialing. All cases resulted in a delay in surgery, with a variance of medical intervention required.