Proteus 235 and Proteus ONE proton therapy systems
Ion Beam Applications S.A.
Class I - Dangerous
Recall is being initiated to address on-site software installations not being performed consistently with IBA standard operating procedures.
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Other Medical Devices
🏥 Medical Devices • 15,809 recalls
Class I - Dangerous
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.
Class I - Dangerous
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.
Alaris PC Unit, Model 8015
CareFusion 303
Class I - Dangerous
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.
Class I - Dangerous
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.
Logic Fit Tibial Tamp Head
Exactech
Class I - Dangerous
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.
LEGION(R) FEM CONE IMPACTOR HEADS: a) REF 71441976, ID 18MM b) REF 71441977, ID 20MM c) REF 71441978, ID 22MM
Smith & Nephew
Class I - Dangerous
The incorrect Loctite adhesive was used to assemble the impactor heads.
SHIMADZU RADspeed Pro Catalog Number: RADspeed Pro; Stationary x-ray system
Shimadzu Medical Systems Usa Com
Class I - Dangerous
Cracks may occur over time on the tube holding shaft near the base of the tube mounting flange.
Class I - Dangerous
A customer experienced when using IMPAX CV Reporting software, specifically, when building a NIV report, the NIV Cardio report was showing incorrect findings for Aneurysm.
Access Thyroglobulin, A34085G, Catalog No. 33860
Beckman Coulter
Class I - Dangerous
The Access immunoassays are susceptible to biotin interference.
Access Total T3, A34435H, Catalog No. 33830
Beckman Coulter
Class I - Dangerous
The Access immunoassays are susceptible to biotin interference.
The Pointe Scientific CK-MB Isoenzyme Control Pointe Scientific CK-MB Level II Control, C7562-12 Control Kit
Medtest Holdings
Class I - Dangerous
Incorrect control range in product labeling
High Frequency Resection Electrodes, endoscope, ac-powered and accessories The electrodes are used for endoscopic diagnosis and treatment in urological and gynecological applications.
Olympus Corporation of the Americas
Class I - Dangerous
Loop wires breaking at the distal end of the Monopolar HF Resection Electrodes.
Class I - Dangerous
The incorrect Loctite adhesive was used to assemble the impactor heads.
SHIMADZU Ceiling Type X-ray Tube Support CH-200/CH-200M Catalog Number: CH-200/CH-200M Holds an x-ray tube unit and collimator combined with an z-ray high voltage generator, radiographic stand, and table. It is designed to perform radiography of patients either in a standing or supine position
Shimadzu Medical Systems Usa Com
Class I - Dangerous
Cracks may occur over time on the tube holding shaft near the base of the tube mounting flange.
Access System-Free T4 Assay, B01902E, Catalog No. 33880
Beckman Coulter
Class I - Dangerous
The Access immunoassays are susceptible to biotin interference.
DePuy Mitek LATARJET EXPERIENCE Coracoid Drill Product Code: 288201 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting the anteroinferior glenoid with a bony graft
DePuy Mitek, Inc., a Johnson & Johnson
Class I - Dangerous
Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operatively when being used at an angle off-axis to screw
Merge OrthoPACS software.
Merge Healthcare
Class I - Dangerous
A migrated study that has annotations will display the annotations, but when a prior study is loaded that should have annotations, the second study will not display annotations.
Dimension Vista Thyroid Stimulating Hormone (TSH) Flex reagent cartridge
Siemens Healthcare Diagnostics
Class I - Dangerous
The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dimension and Dimension Vistat Instructions for Use (IFU) for Dimension TNI, Dimension Vista DIGXN, E2, FERR, PRL, and TSH have incorrect units, and incorrectly state the level at which biotin does not interfere.
DePuy Mitek LATARJET EXPERIENCE Top Hat Tap Product Code: 288203 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting the anteroinferior glenoid with a bony graft
DePuy Mitek, Inc., a Johnson & Johnson
Class I - Dangerous
Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operatively when being used at an angle off-axis to screw