May 28, 2025Medical DevicesFDA
Philips North America Llc recalls Product Name: Ingenia Ambition S; Model Numbers: (1) 781359, (2) 782108, (3) 782139;
Hazard: Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
May 28, 2025Medical DevicesFDA
Philips North America Llc recalls Product Name: Ingenia 3.0T; Model Numbers: (1) 781342, (2) 781377, (3) 782103;
Hazard: Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
May 28, 2025Medical DevicesFDA
Philips North America Llc recalls Product Name: Ingenia 1.5T S; Model Number: 781347;
Hazard: Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
May 28, 2025Medical DevicesFDA
Philips North America Llc recalls Product Name: Ingenia 1.5T; Model Numbers: (1) 781315, (2) 781341, (3) 781396, (4) 782101, (5) 782115, (6) 782140;
Hazard: Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
May 28, 2025Medical DevicesFDA
Philips North America Llc recalls Product Name: Evolution Upgrade 3.0T; Model Numbers: (1) 782117, (2) 782143;
Hazard: Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
May 28, 2025Medical DevicesFDA
Philips North America Llc recalls Product Name: Evolution Upgrade 1.5T; Model Numbers: (1) 782116, (2) 782148;
Hazard: Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
May 28, 2025Medical DevicesFDA
Philips North America Llc recalls Product Name: Upgrade to MR 7700; Model Number: 782130;
Hazard: Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
May 28, 2025Medical DevicesFDA
Philips North America Llc recalls Product Name: SmartPath to Ingenia Elition X; Model Numbers: (1) 782118, (2) 782144;
Hazard: Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
May 28, 2025Medical DevicesFDA
Philips North America Llc recalls Product Name: SmartPath to dStream for XR and 3.0T; Model Numbers: (1) 781270, (2) 782113;
Hazard: Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
May 28, 2025Medical DevicesFDA
Philips North America Llc recalls Product Name: SmartPath to dStream for 3.0T; Model Number: 782145
Hazard: Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
May 28, 2025Medical DevicesFDA
Philips North America Llc recalls Product Name: SmartPath to dStream for 1.5T; Model Numbers: (1) 781260, (2) 782112, (3) 782146
Hazard: Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
May 28, 2025Medical DevicesFDA
Cook Incorporated recalls Check=Flo Performer Introducer, 14.0Fr, Reference Part Number(RPN) REF RCFW-14.0-0-38-30-RB, Order Number (GPN) REF G08
Hazard: Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.
May 28, 2025Medical DevicesFDA
Cook Incorporated recalls Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF RCFW-10.0-0-38-30-RB, Order Number (GPN) REF G08
Hazard: Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.
May 28, 2025Medical DevicesFDA
Echopixel, Inc. recalls True 3D Viewer, Model: EP-00003
Hazard: With certain software versions, import of enhanced ultrasound formatted data/ultrasound images into 3D viewer, (for digital image processing/review/analysis/communication/media interchange acquired from CT/MRI/ultrasound, and pre-operative analysis of surgical options), can result in incorrect display of image orientation, which could result in misdiagnosis or incorrect surgical treatment plan.
May 28, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls Baxter Novum IQ LVP INFUSION SYSTEM, REF 40700BAXUS
Hazard: There is a potential for the Novum IQ LVP due to the potential for underinfusion following use of the "standby mode" feature or if the device is powered off with the set loaded.
May 28, 2025Medical DevicesFDA
Centerline Biomedical Inc recalls Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate through vasculature to facilitate pl
Hazard: Centerline Biomedical has determined that the coating on the guidewires for lot 2404-2005 may delaminate during use of the guidewire.
May 28, 2025Medical DevicesFDA
C.R. Bard Inc recalls Bard¿ Single Intragastric Linton Balloon Tube, REF: 0092740
Hazard: Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric and/or esophageal balloons.
May 28, 2025Medical DevicesFDA
C.R. Bard Inc recalls Bard¿ Blakemore Esophageal-Nasogastric Tube (Intermediate)REF: 0092300
Hazard: Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric and/or esophageal balloons.
May 28, 2025Medical DevicesFDA
C.R. Bard Inc recalls Bard¿ Blakemore Esophageal-Nasogastric Tube (Child) REF: 0092110
Hazard: Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric and/or esophageal balloons.
May 28, 2025Medical DevicesFDA
C.R. Bard Inc recalls Bard Blakemore Esophageal-Nasogastric Tube (Adult) REF: 0092100
Hazard: Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric and/or esophageal balloons.
May 28, 2025Medical DevicesFDA
C.R. Bard Inc recalls Bard Minnesota Four Lumen Esophagogastric Tamponade Tube, REF:0092220 18 Fr. (6mm, 7/32"), 41" Length (104cm) with 8" (2
Hazard: Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric and/or esophageal balloons.
May 28, 2025Medical DevicesFDA
Ethicon Endo-Surgery Inc recalls Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row); Product code VASECR35
Hazard: Firm has received an increase in reports regarding inadvertent instrument lockout during surgical procedures involving the device. If lockout occurs, the device will momentarily activate but will not cut or staple tissue, and additional steps will be required to open it and remove it from tissue. If user is unable to remove the device from the tissue, potential harms to patient include surgical delay, bleeding/hemorrhage, life threatening hemorrhage/hemorrhagic shock, and conversion to open therapy. Two adverse events received, including one patient death.
May 21, 2025Medical DevicesFDA
Beckman Coulter Inc. recalls DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065.
Hazard: Beckman Coulter is recalling their DxC 500 AU Clinical Chemistry Analyzer because a software error causes the analyzer to not run a requested calibration order in the following scenario: when a reagent blank or calibration is ordered during sample processing and then any of the components (R1 and/or R2) depletes to zero tests, the analyzer will not be able to complete the calibration request, and the calibration order will remain pending. No further calibration orders can be processed for any assays, and the instrument refuses to accept further sample processing order after the existing calibration curves are expired. Although in-process tests will be completed, this error can cause a delay in reporting subsequent test results. No further calibration orders can be processed for any assays which may cause a delay in reporting test results.
May 21, 2025Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls SmartPath to dStream for 3.0T, Model Number: 782145;
Hazard: The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
May 21, 2025Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls SmartPath to dStream for 1.5T, Model Number: 782146;
Hazard: The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
May 21, 2025Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Intera CV, Model Number: 781107;
Hazard: The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
May 21, 2025Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Intera 3.0T Quasar Dual, Model Number: 781150;
Hazard: The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
May 21, 2025Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Intera 1.5T R11, Model Number: 781170;
Hazard: The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
May 21, 2025Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Intera 1.5T Power/Pulsar, Model Number: 781105;
Hazard: The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
May 21, 2025Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Intera 1.5T Omni/Stellar, Model Number: 781104;
Hazard: The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.