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Abbott Medical: Proclaim" XR 7 Implantable Pulse Generator REF 3662 (prev...
Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).
FDAJul 18, 2023Nationwide• Abbott Medical
Preat Corp: Preat REF 9007123, Neodent GM x 4mm Healing Abutment, Rx ...
The healing abutments contain a dimensional condition that may lead to a gap between the healing abutment and the implant allowing for microleakage
FDAJul 18, 2023CA, FL, NJ +4 more• Preat Corp
Preat Corp: Preat REF 9007121, Neodent GM x 2mm Healing Abutment, Rx ...

Siemens Medical Solutions USA, Inc.: ACUSON Redwood 2.0 ultrasound systems, REF: 11503314
If a user-generated preset for an 18L6 transducer created on a 1.0 ultrasound system is used with a 2.0 ultrasound system, the 2.0 ultrasound system will display underestimated measurement results when using an 18L6 transducer and viewing in the Dual format visualization function, which may lead to misdiagnosis of a patient's condition or influence patient management decisions in a negative way.
FDAJul 13, 2023Nationwide• Siemens Medical Solutions USA, Inc.

Siemens Medical Solutions USA, Inc.: The following Pro.specta Emission Computed Tomography Sys...
During a whole-body planar scan with auto-contour, there is a possibility the short-linear drive (SLD) look-ahead sensors may trigger earlier than expected and may result in detector 1 positioning further from the patient than needed leading to a reduction in image resolution.
FDAJul 12, 2023ID, KS, MA +4 more• Siemens Medical Solutions USA, Inc.

Alphatec Spine, Inc. 1950 Camino Vida Roble: LIF AMP, Adjustable Awl, REF 117-165, Part of the AMP Sys...
Awl instrument adjustable drill button assembly assembled in the incorrect orientation, preventing locking feature from engaging with shaft at the desired set point; instruments lack ability to control awl depth by means of adjustable shaft advancement stop, which may lead to over insertion, dural tear, vascular/neurologic injury, adjacent tissue damage, increased operative time, revision surgery.
FDAJul 7, 2023Nationwide• Alphatec Spine, Inc. 1950 Camino Vida Roble

Unknown Manufacturer: MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis ...
Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, partially or fully, and/or uncured or excessive MDX may dislodge from the catheter lead to full catheter obstruction resulting in delay to treatment and partial obstruction resulting in reduced flow, or particulate dislodgement that may result in delay to treatment, hemolysis, embolism/embolus or thrombosis/thrombus
FDAJun 28, 2023Nationwide

Unknown Manufacturer: MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 c...
Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, partially or fully, and/or uncured or excessive MDX may dislodge from the catheter lead to full catheter obstruction resulting in delay to treatment and partial obstruction resulting in reduced flow, or particulate dislodgement that may result in delay to treatment, hemolysis, embolism/embolus or thrombosis/thrombus
FDAJun 28, 2023Nationwide

Cytrellis Biosystems, Inc.: ellacor System with Micro-Coring Technology-Indicated for...
Potential failure of a bearing adhesive joint that can occur due to an assembly issue of the X/Y stage of the handpiece. If a broken glue bond were to occur, it could cause an overlap of cores, potentially leading to prolonged healing and irregularities in patient skin texture post-treatment, and/or scarring
FDAJun 23, 2023Nationwide• Cytrellis Biosystems, Inc.

Beckman Coulter, Inc.: Ringed DxI Reaction Vessels (RVs)
Beckman Coulter, Inc. is recalling Ringed DxI Reaction Vessels (RVs) as part of Unicel DxI Immunoassay System (600, 800 series). The reason for the recall is that the firm has identified 3 lots of RVs that failed an internally used service test to evaluate washing efficiency. Increased relative light units (RLU) suspected to be caused by the resulting rough interior surface may lead to artificially falsely elevated results for susceptible tests, in particular, sandwich assays including, but not limited to, hsTnI, Hybritech p2PSA, IPTH/IPTH IO.
FDAJun 20, 2023Nationwide• Beckman Coulter, Inc.

Megadyne Medical Products, Inc.: MEGADYNE Suction Coagulators, Product Code 004125 (Suctio...
An issue with the Suction Coagulator product family may lead to fluid ingress into the handpiece. Fluid ingress can lead to intermittent device activation, non-activation, or self-activation when plugged into the electrosurgery unit (ESU).
FDAJun 15, 2023Nationwide• Megadyne Medical Products, Inc.

Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland: Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbe...
Carryover from the Direct LDL-cholesterol assay on the Rx instruments may result in a negative bias, up to -11%, in quality control and patient samples, in urea assays results if the urea assay is run immediately after the Direct LDL-cholesterol assay. This may lead to a delay in reporting results or in falsely decreased urea test results.
FDAJun 13, 2023Nationwide• Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland

Intuitive Surgical, Inc.: da Vinci Xi/X Tip-Up Fenestrated Grasper, REF: 470347, VE...
Fenestrated Graspers have a manufacturing issue has the potential to cause breakage on both upper and/or lower grips, which could lead to stainless steel fragments falling into the patient that may be either detected or undetected.
FDAJun 12, 2023Nationwide• Intuitive Surgical, Inc.

NeuroLogica Corporation: OmniTom/OmniTom Elite- X-ray computed tomography applicat...
1. Wheels loosening over time with use of the device could lead to the inability to effectively drive the device and could lead to delay in patient treatment. 2.Batteries used to power the NL5000 device contain contaminated boards, which may impact the ability to power on the device, this could lead to delay for patient treatment
FDAJun 6, 2023Nationwide• NeuroLogica Corporation

Datascope Corp.: Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model...
An unexpected shutdown of the IABP may occur due to failures of tantalum capacitors in the Power Management Board and/or Solenoid Board. This issue may lead to an unexpected interruption of therapy.
FDAJun 5, 2023Nationwide• Datascope Corp.

Datascope Corp.: Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model...
An unexpected shutdown of the IABP may occur due to failures of tantalum capacitors in the Power Management Board and/or Solenoid Board. This issue may lead to an unexpected interruption of therapy.
FDAJun 5, 2023Nationwide• Datascope Corp.

Beckman Coulter Biomedical GmbH Sauerbruchstr. 50 Munchen Germany: Beckman Coulter DxA Automation System, DxA 5000, REF: B87...
A software defect in the DxA Automation System may cause tests to be run on patient samples in tube types not compatible with the requested test, leading to erroneous patient results
FDAJun 2, 2023AL, CA, FL +16 more• Beckman Coulter Biomedical GmbH Sauerbruchstr. 50 Munchen Germany