🏥 Medical Devices Class I - Dangerous
Potential for microbial contamination.
All Recalls
95,102 total recalls in our database
🏥 Medical Devices Class I - Dangerous
Due to mislabeling of products
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
🏥 Medical Devices 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.
🏥 Medical Devices 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 Power/Pulsar, Model Number: 781105;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
🏥 Medical Devices 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.
🏥 Medical Devices Class I - Dangerous
Potential for DC Power Supply housing to become hot to the touch and deform the plastic housing.
Intera 1.5T R11, Model Number: 781170;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
🏥 Medical Devices 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.
LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1 and v2.2
ICU Medical
🏥 Medical Devices Class I - Dangerous
Firm has identified Drug Library Management defects in the software: 1) DLM software does not allow user to create percentage dose rate or rate change values with certain limits, potentially resulting in over-delivery to patient. 2) An unauthorized user may modify and approve a drug library, potentially leading to incorrect program parameters being used for therapy.
Intera 1.5T, Model Numbers: 781195 and 781295;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
🏥 Medical Devices 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 1.0T Power/Pulsar, Model Number: 781103;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
🏥 Medical Devices 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.
🏥 Medical Devices Class I - Dangerous
Due to mislabeling of products
🏥 Medical Devices 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.
Pruitt Occlusion Catheter. Catalog Numbers: 2103-36, 2103-46, 2103-56, E2103-36, E2103-46, E2103-56
LeMaitre Vascular
🏥 Medical Devices Class I - Dangerous
During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
🏥 Medical Devices Class I - Dangerous
During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
MedicaLyte Liquid Bicarbonate Concentrate. Model Numbers: BC+201 (45X), BC+100 36.83X. Plastic bottle packaged in corrugated shipper cases (4 bottles per shipper case).
Nipro Renal Soultions USA
🏥 Medical Devices Class I - Dangerous
Potential for the presence of visible foreign matter.
Intera CV, Model Number: 781107;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
🏥 Medical Devices 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.
🏥 Medical Devices Class I - Dangerous
The perc pin adaptor AMCH07200 tightening knob was found to be inconvenient to the user and the tightening markings found to be improperly placed.
🏥 Medical Devices Class I - Dangerous
Potential for microbial contamination.
CMS8000 Patient Monitor
Contec Medical Systems Co.
🏥 Medical Devices Class I - Dangerous
Patient monitor has nine identified cybersecurity vulnerabilities.
🏥 Medical Devices Class I - Dangerous
A cybersecurity vulnerability was discovered through internal testing.