Lack of 510k clearance for design modification.
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Infusion Pumps
🏥 Medical Devices • 4,262 recalls
If a reader selects Multi-study review prior to the original study completing its loading process and then immediately returns to image review of the original study, it is possible that not all current images will be present for review, which could result in incorrect treatment/diagnosis.
Absent tantalum market pin.
Labeling mix-up: Futurabond M+ DCA (Dual Cure Activator) was marked labeled as Futurabond M+ Universal Adhesive.
Class I - Dangerous
Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor System because the hose may come loose and cause a leak.
SOMATOM Perspective, Computed tomography x-ray system
Siemens Medical Solutions USA
Class I - Dangerous
Siemens is providing a new installation of the Residual Current Monitor (RCM) in the Line Connection Box (LCB) to resolve a potential defect that could lead to a power cutout during use of the SOMATOM Scope, Scope Power and Perspective systems.
NIM EMG Endotracheal Tube, 6.0 mm I.D. x 8.8 mm O.D. (27 FR), Reinforced, Sterile, Rx only. Individually packaged.
Medtronic Xomed
Class I - Dangerous
Wire in tubing can become exposed, posing potential harm to the intubated patient.
Class I - Dangerous
BD has confirmed that a portion of BD SurePath" collection vials associated with specific production lots may contain caps that are cracked which can lead to leaking of the preservative fluid.
Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.
Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.
Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.
Class I - Dangerous
Owens & Minor is the initial importer and private label distributor of Medi Choice Arm Slings (Product). The Product is manufactured in China by Tops Medical Articles Nantong Inc. Owens & Minor first learned of the product issue that prompted the product removal action via customer complaints received in September 2016. Two customer complaints received on September 1"1, 2016 reported surface contamination on the arm slings. Two additional complaints reported on September 19, 2016 and October 7, 2016 reported the same issue. Upon receipt of the complaints on September 1, 2016, Owens & Minor immediately initiated a CAPA investigation for root cause analysis and determination of corrective/preventive actions. A quality inspection of inventory confirmed that the surface contamination was confined to lots manufactured in May, June, and July of 2016. The surface contamination for these lots was found to be frequent. Subsequent August product lots were inspected and no surface contamination was found. Limited inventory from lots prior to May 2016 were available and inspected as well. No surface contamination was found on these prior lots. Owens & Minor has quarantined the affected product lots. The product is on hold at all Owens & Minor Distribution Centers (DC). Samples of contaminated product have been sent to the manufacturer for evaluation and to a certified testing lab for identification of contaminate. These results are pending at this time. Based on the frequency of the product defect as well as evaluation of potential adverse health event risk, Owens & Minor initiated a voluntary recall for the above stated affected product lots.
Ultroid Sterile Disposable Probes sold individually
Ultroid Technologies
Class I - Dangerous
Products are not designed, qualified, manufactured, and/or managed under a state of control per internal quality system procedures and external laws, regulations, directives, standards, and/or guidance (such as 21 CFR 820 Quality System Regulation)
Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.
Nuvectra is conducting a recall due to two clinical risks that are associated with certain percutaneous leads currently being used in the Algovita Spinal Cord Stimulation System. It has been reported that in some percutaneous leads, the stylet protruded beyond the distal lead tip.
Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.
Edits to Particle field definition parameters may not be saved when the field definition window is saved.
If images are sent without an order in the system, they will be matched with the latest order on the current patient/modality matching potentially resulting in the matching of the report to the incorrect accession number (but still associated to the correct patient).
Reporting feature times out after inactivity for more than an hour sending the user back to the study list, which causes all reporting data being entered to be lost.
IVEA 500A Intended for Med-Surg patient care.
Firefly Medical
Class I - Dangerous
The dowel pin could potentially slip out of its press fit, resulting in the product potentially slumping to one side which could cause the patient to stumble.