Hidrex USA DVP1000
Hidrex GmbH
Class I - Dangerous
The device was reclassified from a class III device to a class II device and there are new documentation requirements.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Hidrex USA DP450
Hidrex GmbH
Class I - Dangerous
The device was reclassified from a class III device to a class II device and there are new documentation requirements.
Class I - Dangerous
The firm confirmed a reduced once-opened and on-board stability for N Latex Homocysteine (HCY) OPAX03 lot 802907632 that may result in erroneously reduced or elevated homocysteine values. The stability issue may lead to higher than expected lot-to-lot variation and an impaired product performance.
Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal after being depressed.
Atrium PVC 8 Fr Straight Thoracic Catheter Code Number: 8008
Atrium Medical
Class I - Dangerous
Labeling icon depicts a catheter having six (6) eyelets; however the correct number of eyelets on the 8 Fr and 10 Fr thoracic catheters is two (2)
STERRAD NX Sterilization System, Product Code: 10033, 10033-002
Advanced Sterilization Products
Class I - Dangerous
Advanced Sterilization Products (ASP) has identified that in a rare sequence of events following an external power outage, the system door interlock can be become disengaged during system reboot for a 20-second duration.
StarClose SE Vascular Closure System, Part No. 14679-01, 14679-02. The UDI is 08717648079467. The GMDN is 47411.
Abbott Vascular
Class I - Dangerous
Abbott Vascular is recalling the StarClose SE Vascular Closure System because it may exhibit difficulty or failure to deploy the StarClose SE Clip.
Class I - Dangerous
Zimmer Biomet is conducting a medical device recall for ARCOS & TPRLC broaches and rasps due to potential alumina inclusions in the raw material batch used to produce the affected products. Inclusions contained within the finished product could lead to the cracking and separation of the instrument.
ONCOR Avant-garde, medical charged-particle radiation therapy system Product Usage: The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer.
Siemens Medical Solutions USA
Class I - Dangerous
Siemens became aware of Incorrect values for the rotational collimator position displayed due to mechanical problems of the sensor slide. In addition, there are improper weld seam at the overhead suspension.
HARVEST NEEDLE 15GA X 2 Intended for the purpose of harvesting bone and/or bone marrow specimens
Argon Medical Devices
Class I - Dangerous
The recalling firm received a complaint from one of their customers of a potential defect in the forming of the primary package of the blister that may compromise the sterility of the product inside the tray.
Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal after being depressed.
GN200 Caiman HF generators, electrosurgical, cutting & coagulation & accessories
Aesculap Implant Systems
Class I - Dangerous
Generators may have a faulty component which could impact the proper functioning of the device.
Class I - Dangerous
Higher than anticipated rate of fracturing due to design. Risk of revision surgery due to fracturing.
ARTISTE MV System, medical charged-particle radiation therapy system Product Usage: The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer.
Siemens Medical Solutions USA
Class I - Dangerous
Siemens became aware of Incorrect values for the rotational collimator position displayed due to mechanical problems of the sensor slide. In addition, there are improper weld seam at the overhead suspension.
The Schiller PB 1000, also known as: Merge Hemo Patient Data Module (PDM), V2 model, a major component of the Merge Hemo software.
Merge Healthcare
Class I - Dangerous
Non-invasive blood pressure pumps (NIBP) voltage is not sufficient and causes the NIBP pumps to fail prior to reaching adequate initial pressure.
The Enzyme II Calibrator is an in vitro diagnostic product for the Alanine Aminotransferase (ALTI) on the Dimension¿ clinical chemistry system. For prescription use only.
Siemens Healthcare Diagnostics
Class I - Dangerous
Complaints of positive shift of patient and QC results when the ALTI assay is calibrated with the Dimension Enzyme II calibrator. Internal investigation has confirmed that patient samples and QC material demonstrate a shift of up to 10% in comparison to results obtained using earlier calibrator lots.
Lima Proximal Bodies were inadvertently re-sterilized. The safety screw which affixes the distal and proximal bodies of the stem includes a thread-locking plug made from UHMWPE, which is not approved for repeated gamma sterilization.
PRIMUS Medical charged-particle radiation therapy system Product Usage: The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer.
Siemens Medical Solutions USA
Class I - Dangerous
Siemens became aware of Incorrect values for the rotational collimator position displayed due to mechanical problems of the sensor slide. In addition, there are improper weld seam at the overhead suspension.
Class I - Dangerous
Siemens became aware of Incorrect values for the rotational collimator position displayed due to mechanical problems of the sensor slide. In addition, there are improper weld seam at the overhead suspension.
Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal after being depressed.