Class I - Dangerous
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.
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Other Medical Devices
🏥 Medical Devices • 15,809 recalls
Class I - Dangerous
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.
Product Name: MR 5300; Model Numbers: (1) 782110, (2) 782152;
Philips North America
Class I - Dangerous
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Product Name: Ingenia 1.5T; Model Numbers: (1) 781315, (2) 781341, (3) 781396, (4) 782101, (5) 782115, (6) 782140;
Philips North America
Class I - Dangerous
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Product Name: Upgrade to MR 7700; Model Number: 782130;
Philips North America
Class I - Dangerous
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
True 3D Viewer, Model: EP-00003
Echopixel
Class I - Dangerous
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.
Intera 1.5T Master/Nova, Model Number: 781106;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Class I - Dangerous
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.
SmartPath to dStream for 3.0T, Model Number: 782145;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Class I - Dangerous
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.
Intera 1.5T Explorer/Nova Dual, Model Number: 781108;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Class I - Dangerous
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.
Centurion Sterile Weitlaner Retractor 3 x 4 Prong, Reorder: I68395
MEDLINE INDUSTRIES, LP - Northfield
Class I - Dangerous
Three is the potential for the retractors to puncture through the sterile packaging.
SmartPath to dStream for 1.5T, Model Number: 782146;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Class I - Dangerous
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.
Class I - Dangerous
An issue with a raw material used to coat some surgical needles that may result in diminished performance and/or removal of some silicone needle coating during use.
Intera 1.0T Omni/Stellar, Model Number: 781102;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Class I - Dangerous
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.
Class I - Dangerous
An issue with a raw material used to coat some surgical needles that may result in diminished performance and/or removal of some silicone needle coating during use.
Enterprise 1.5T, Model Number: 781145;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Class I - Dangerous
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.
Class I - Dangerous
The high voltage capacitor may fail early in the product life cycle after delivery of surge voltages. When this failure occurs, the capacitor may produce smoke and a burning smell. In extremely rare instances a capacitor may cause a spark or excessive heat when an internal capacitor failure occurs.
Intera 1.5T Omni/Stellar, Model Number: 781104;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Class I - Dangerous
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.
Intera 0.5T Standard, Model Number: 781101;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Class I - Dangerous
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.
Welch Allyn Life2000 Compressor, Product Codes: 1) BT-80-0004; 2) BT-80-0004A; 3) BT-80-0008; 4) BT-80-0008A; 5) RMS010093CP.
Baxter Healthcare
Class I - Dangerous
A cybersecurity vulnerability was discovered through internal testing.
Intera 3.0T Quasar Dual, Model Number: 781150;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Class I - Dangerous
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.